Title 49—Transportation--Volume 1
PART 40—PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS
§ 40.1   Who does this regulation cover?
(a) This part tells all parties who conduct drug and alcohol tests required by Department of Transportation (DOT) agency regulations how to conduct these tests and what procedures to use.
(b) This part concerns the activities of transportation employers, safety-sensitive transportation employees (including self-employed individuals, contractors and volunteers as covered by DOT agency regulations), and service agents.
(c) Nothing in this part is intended to supersede or conflict with the implementation of the Federal Railroad Administration's post-accident testing program (see 49 CFR 219.200).
§ 40.3   What do the terms used in this part mean?
In this part, the terms listed in this section have the following meanings:
Adulterated specimen. A specimen that has been altered, as evidenced by test results showing either a substance that is not a normal constituent for that type of specimen or showing an abnormal concentration of an endogenous substance.
Affiliate. Persons are affiliates of one another if, directly or indirectly, one controls or has the power to control the other, or a third party controls or has the power to control both. Indicators of control include, but are not limited to: interlocking management or ownership; shared interest among family members; shared facilities or equipment; or common use of employees. Following the issuance of a public interest exclusion, an organization having the same or similar management, ownership, or principal employees as the service agent concerning whom a public interest exclusion is in effect is regarded as an affiliate. This definition is used in connection with the public interest exclusion procedures of Subpart R of this part.
Air blank. In evidential breath testing devices (EBTs) using gas chromatography technology, a reading of the device's internal standard. In all other EBTs, a reading of ambient air containing no alcohol.
Alcohol. The intoxicating agent in beverage alcohol, ethyl alcohol or other low molecular weight alcohols, including methyl or isopropyl alcohol.
Alcohol concentration. The alcohol in a volume of breath expressed in terms of grams of alcohol per 210 liters of breath as indicated by a breath test under this part.
Alcohol confirmation test. A subsequent test using an EBT, following a screening test with a result of 0.02 or greater, that provides quantitative data about the alcohol concentration.
Alcohol screening device (ASD). A breath or saliva device, other than an EBT, that is approved by the National Highway Traffic Safety Administration (NHTSA) and appears on ODAPC's Web page for “Approved Screening Devices to Measure Alcohol in Bodily Fluids” because it conforms to the model specifications from NHTSA.
Alcohol screening test. An analytic procedure to determine whether an employee may have a prohibited concentration of alcohol in a breath or saliva specimen.
Alcohol testing site. A place selected by the employer where employees present themselves for the purpose of providing breath or saliva for an alcohol test.
Alcohol use. The drinking or swallowing of any beverage, liquid mixture or preparation (including any medication), containing alcohol.
Aliquot. A fractional part of a specimen used for testing. It is taken as a sample representing the whole specimen.
Alternate specimen. An authorized specimen, other than the type of specimen previously collected or attempted to be collected.
Breath Alcohol Technician (BAT). A person who instructs and assists employees in the alcohol testing process and operates an evidential breath testing device.
Cancelled test. A drug or alcohol test that has a problem identified that cannot be or has not been corrected, or which this part otherwise requires to be cancelled. A cancelled test is neither a positive nor a negative test.
Chain of custody. The procedure used to document the handling of the urine specimen from the time the employee gives the specimen to the collector until the specimen is destroyed. This procedure uses the Federal Drug Testing Custody and Control Form (CCF) as approved by the Office of Management and Budget.
Collection container. A container used to collect a specimen.
Collection site. A place selected by the employer where employees present themselves for the purpose of providing a specimen for a drug test.
Collector. A person who instructs and assists employees at a collection site, who receives and makes an initial inspection of the specimen provided by those employees, and who initiates and completes the CCF.
Commercial Driver's License Drug and Alcohol Clearinghouse (Clearinghouse). A database, administered by the Federal Motor Carrier Safety Administration, containing records of commercial motor vehicle drivers' violations of controlled substances and alcohol testing program requirements, as set forth in part 382 of this title, as well as their return-to-duty status.
Confirmatory drug test. A second analytical procedure performed on a different aliquot of the original specimen to identify and quantify a specific drug or drug metabolite.
Confirmatory validity test. A second test performed on a different aliquot of the original urine specimen to further support a validity test result.
Confirmed drug test. A confirmation test result received by an MRO from a laboratory.
Consortium/Third-party administrator (C/TPA). A service agent that provides or coordinates the provision of a variety of drug and alcohol testing services to employers. C/TPAs typically perform administrative tasks concerning the operation of the employers' drug and alcohol testing programs. This term includes, but is not limited to, groups of employers who join together to administer, as a single entity, the DOT drug and alcohol testing programs of its members. C/TPAs are not “employers” for purposes of this part.
Continuing education. Training for substance abuse professionals (SAPs) who have completed qualification training and are performing SAP functions, designed to keep SAPs current on changes and developments in the DOT drug and alcohol testing program.
Cutoff. The analytical value ( e.g., drug or drug metabolite concentration) used as the decision point to determine a result ( e.g., negative, positive, adulterated, invalid, or substituted) or the need for further testing.
Designated employer representative (DER). An employee authorized by the employer to take immediate action(s) to remove employees from safety-sensitive duties, or cause employees to be removed from these covered duties, and to make required decisions in the testing and evaluation processes. The DER also receives test results and other communications for the employer, consistent with the requirements of this part. Service agents cannot act as DERs.
Dilute specimen. A urine specimen with creatinine and specific gravity values that are lower than expected for human urine.
DOT, The Department, DOT Agency. These terms encompass all DOT agencies, including, but not limited to, the Federal Aviation Administration (FAA), the Federal Railroad Administration (FRA), the Federal Motor Carrier Safety Administration (FMCSA), the Federal Transit Administration (FTA), the National Highway Traffic Safety Administration (NHTSA), the Pipeline and Hazardous Materials Safety Administration (PHMSA), and the Office of the Secretary (OST). For purposes of this part, the United States Coast Guard (USCG), in the Department of Homeland Security, is considered to be a DOT agency for drug testing purposes only since the USCG regulation does not incorporate Part 40 for its alcohol testing program. These terms include any designee of a DOT agency.
Drugs. The drugs for which tests are required under this part and DOT agency regulations are marijuana, cocaine, amphetamines, phencyclidine (PCP), and opioids.
Employee. Any person who is designated in a DOT agency regulation as subject to drug testing and/or alcohol testing. The term includes individuals currently performing safety-sensitive functions designated in DOT agency regulations and applicants for employment subject to pre-employment testing. For purposes of drug testing under this part, the term employee has the same meaning as the term “donor” as found on CCF and related guidance materials produced by the Department of Health and Human Services.
Employer. A person or entity employing one or more employees (including an individual who is self-employed) subject to DOT agency regulations requiring compliance with this part. The term includes an employer's officers, representatives, and management personnel. Service agents are not employers for the purposes of this part.
Error Correction Training. Training provided to BATs, collectors, and screening test technicians (STTs) following an error that resulted in the cancellation of a drug or alcohol test. Error correction training must be provided in person or by a means that provides real-time observation and interaction between the instructor and trainee.
Evidential Breath Testing Device (EBT). A device that is approved by the National Highway Traffic Safety Administration (NHTSA) for the evidential testing of breath at the .02 and .04 alcohol concentrations, and appears on ODAPC's Web page for “Approved Evidential Breath Measurement Devices” because it conforms with the model specifications available from NHTSA.
HHS. The Department of Health and Human Services or any designee of the Secretary, Department of Health and Human Services.
Initial drug test. The first test used to differentiate a negative specimen from one that requires further testing for drugs or drug metabolites.
Initial specimen validity test. The first test used to determine if a specimen is adulterated, diluted, substituted, or invalid.
Invalid result. The result reported by an HHS-certified in accordance with the criteria established by HHS when a positive, negative, adulterated, or substituted result cannot be established for a specific drug or specimen validity test.
Laboratory. Any U.S. laboratory certified by HHS under the National Laboratory Certification Program as meeting the minimum standards set by HHS; or, in the case of foreign laboratories, a laboratory approved for participation by DOT under this part.
Limit of Detection (LOD). The lowest concentration at which the analyte ( e.g., drug or drug metabolite) can be identified.
Limit of Quantitation (LOQ). For quantitative assays, the lowest concentration at which the identity and concentration of the analyte ( e.g., drug or drug metabolite) can be accurately established.
Medical Review Officer (MRO). A person who is a licensed physician and who is responsible for receiving and reviewing laboratory results generated by an employer's drug testing program and evaluating medical explanations for certain drug test results.
Negative result. The result reported by an HHS-certified laboratory to an MRO when a specimen contains no drug or the concentration of the drug is less than the cutoff concentration for the drug or drug class and the specimen is a valid specimen.
Non-negative specimen. A specimen that is reported as adulterated, substituted, positive (for drug(s) or drug metabolite(s)), or invalid.
Office of Drug and Alcohol Policy and Compliance (ODAPC). The office in the Office of the Secretary, DOT, that is responsible for coordinating drug and alcohol testing program matters within the Department and providing information concerning the implementation of this part.
Oral fluid specimen. A specimen that is collected from an employee's oral cavity and is a combination of physiological fluids produced primarily by the salivary glands. An oral fluid specimen is considered to be a direct observation collection for all purposes of this part.
Oxidizing adulterant. A substance that acts alone or in combination with other substances to oxidize drugs or drug metabolites to prevent the detection of the drug or drug metabolites, or affects the reagents in either the initial or confirmatory drug test.
Primary specimen. In drug testing, the specimen bottle that is opened and tested by a first laboratory to determine whether the employee has a drug or drug metabolite in his or her system; and for the purpose of specimen validity testing. The primary specimen is the portion of the donor's subdivided specimen designated as the primary (“A”) specimen by the collector to distinguish it from the split (“B”) specimen, as defined in this section.
Positive result. The result reported by an HHS-certified laboratory when a specimen contains a drug or drug metabolite equal to or greater than the cutoff concentrations.
Qualification Training. The training required in order for a collector, BAT, MRO, SAP, or STT to be qualified to perform their functions in the DOT drug and alcohol testing program. Qualification training may be provided by any appropriate means ( e.g., classroom instruction, internet application, CD-ROM, video).
Reconfirmed. The result reported for a split (Bottle B) specimen when the second HHS-certified laboratory corroborates the original result reported for the primary (Bottle A) specimen.
Refresher Training. The training required periodically for qualified collectors, BATs, and STTs to review basic requirements and provide instruction concerning changes in technology ( e.g., new testing methods that may be authorized) and amendments, interpretations, guidance, and issues concerning this part and DOT agency drug and alcohol testing regulations. Refresher training can be provided by any appropriate means ( e.g., classroom instruction, internet application, CD-ROM, video).
Rejected for testing. The result reported by an HHS-certified laboratory when no tests are performed for a specimen because of a fatal flaw or a correctable flaw that is not corrected.
Screening Test Technician (STT). A person who instructs and assists employees in the alcohol testing process and operates an ASD.
Secretary. The Secretary of Transportation or the Secretary's designee.
Service agent. Any person or entity, other than an employee of the employer, who provides services to employers and/or employees in connection with DOT drug and alcohol testing requirements. This includes, but is not limited to, collectors, BATs and STTs, laboratories, MROs, substance abuse professionals, and C/TPAs. To act as service agents, persons and organizations must meet DOT qualifications, if applicable. Service agents are not employers for purposes of this part.
Shipping container. A container that is used for transporting and protecting specimen bottles and associated documents from the collection site to the laboratory.
Specimen. Fluid, breath, or other material collected from an employee at the collection site for the purpose of a drug or alcohol test.
Specimen bottle. The bottle that, after being sealed and labeled according to the procedures in this part, is used to hold a primary (“A”) or split (“B”) specimen during transportation to the laboratory. In the context of oral fluid testing, it may be referred to as a “vial,” “tube,” or “bottle.”
Split specimen. In drug testing, the specimen that is sent to a first laboratory and stored with its original seal intact, and which is transported to a second laboratory for retesting at the employee's request following MRO verification of the primary specimen as positive, adulterated or substituted.
Split specimen collection. A collection in which the single specimen collected is divided into two separate specimen bottles, the primary specimen (Bottle A) and the split specimen (Bottle B).
SSN or Employee ID No. This number serves as a unique identifier that must be used on the Federal Drug Testing Custody and Control Form (CCF) or Alcohol Testing Form (ATF) for a donor, on the MRO's reports, on SAP reports, or on other documents that are required under this part. For all purposes of this part, this term means: only the Commercial Driver's License (CDL) Number and State of issuance for drivers tested under the authority of the Federal Motor Carrier Safety Administration (FMCSA); and, for all drivers and other safety-sensitive employees tested under the authority of the other DOT agencies, this can be the individual's actual Social Security Number, a unique identifier issued by the employer, a State-issued identification card number, a State-issued driver's license number (including a CDL number) or any other State-issued or federally-issued identification number.
Stand-down. The practice of temporarily removing an employee from the performance of safety-sensitive functions based only on a report from a laboratory to the MRO of a confirmed positive test for a drug or drug metabolite, an adulterated test, or a substituted test, before the MRO has completed verification of the test result.
Substance Abuse Professional (SAP). A person who evaluates employees who have violated a DOT drug and alcohol regulation and makes recommendations concerning education, treatment, follow-up testing, and aftercare.
Substituted specimen. An employee's specimen not consistent with a normal human specimen, as determined by HHS ( e.g., a urine specimen, with creatinine and specific gravity values that are so diminished, or so divergent that they are not consistent with normal human urine).
Undiluted (neat) oral fluid. An oral fluid specimen to which no other solid or liquid has been added. For example: A collection device that uses a diluent (or other component, process, or method that modifies the volume of the testable specimen) must collect at least 1 mL of undiluted (neat) oral fluid.
Urine specimen. Urine collected from an employee at the collection site for the purpose of a drug test.
Verified test. A drug test result or validity testing result from an HHS-certified laboratory that has undergone review and final determination by the MRO.
§ 40.5   Who issues authoritative interpretations of this regulation?
ODAPC and the DOT Office of General Counsel (OGC) provide written interpretations of the provisions of this part. These written DOT interpretations are the only official and authoritative interpretations concerning the provisions of this part. DOT agencies may incorporate ODAPC/OGC interpretations in written guidance they issue concerning drug and alcohol testing matters. Only Part 40 interpretations issued after August 1, 2001, are considered valid.
§ 40.7   How can you get an exemption from a requirement in this regulation?
(a) If you want an exemption from any provision of this part, you must request it in writing from the Office of the Secretary of Transportation, under the provisions and standards of 49 CFR part 5. You must send requests for an exemption to the following address: Department of Transportation, Deputy Assistant General Counsel for Regulation and Enforcement, 1200 New Jersey Avenue, SE., Washington, DC 20590.
(b) Under the standards of 49 CFR part 5, we will grant the request only if the request documents special or exceptional circumstances, not likely to be generally applicable and not contemplated in connection with the rulemaking that established this part, that make your compliance with a specific provision of this part impracticable.
(c) If we grant you an exemption, you must agree to take steps we specify to comply with the intent of the provision from which an exemption is granted.
(d) We will issue written responses to all exemption requests.
§ 40.11   What are the general responsibilities of employers under this regulation?
(a) As an employer, you are responsible for meeting all applicable requirements and procedures of this part.
(b) You are responsible for all actions of your officials, representatives, and agents (including service agents) in carrying out the requirements of the DOT agency regulations.
(c) All agreements and arrangements, written or unwritten, between and among employers and service agents concerning the implementation of DOT drug and alcohol testing requirements are deemed, as a matter of law, to require compliance with all applicable provisions of this part and DOT agency drug and alcohol testing regulations. Compliance with these provisions is a material term of all such agreements and arrangements.
§ 40.13   How do DOT drug and alcohol tests relate to non-DOT tests?
(a) DOT tests must be completely separate from non-DOT tests in all respects.
(b) DOT tests must take priority and must be conducted and completed before a non-DOT test is begun. When conducting a urine DOT drug test, you must discard any excess urine left over from a DOT test and collect a separate urine void for the subsequent non-DOT test.
(c) Except as provided in paragraph (d) of this section, you must not perform any tests on DOT specimens other than those tests specifically authorized by this part or DOT agency regulations. For example, you must not test a DOT specimen for additional drugs. In addition, a laboratory is prohibited from making a DOT specimen available for a DNA test or other types of specimen identity testing.
(d) When a DOT urine drug test collection is conducted as part of a physical examination required by DOT agency regulations, it is permissible to conduct medical tests related to this physical examination ( e.g., for glucose) on any specimen remaining in the collection container after the DOT portion has been sealed into the specimen bottles.
(e) A non-DOT drug or alcohol test administered, as part of a physical examination, is not a DOT drug or alcohol test for purposes of this part and/or related DOT agency drug and alcohol testing rules, if that test was performed to determine if an employee is medically qualified for a license or certificate. Consequently, the results of such a test do not have consequences under this part.
(f) No one is permitted to change or disregard the results of DOT tests based on the results of non-DOT tests. For example, as an employer you must not disregard a verified positive DOT drug test result because the employee presents a negative test result from a blood or urine specimen collected by the employee's physician or a DNA test result purporting to question the identity of the DOT specimen.
(g) As an employer, you must not use the CCF or the ATF in your non-DOT drug and alcohol testing programs. This prohibition includes the use of the DOT forms with references to DOT programs and agencies crossed out. You also must always use the CCF and ATF for all your DOT-mandated drug and alcohol tests.
(h) No one is permitted to conduct a DOT drug or alcohol test on an individual who is not a DOT-regulated employee, as defined by the DOT agency regulations.
§ 40.14   What collection information must employers provide to collectors?
As an employer, or an employer's service agent—for example a C/TPA, you must ensure the collector has the following information when conducting a specimen collection for you:
(a) Full name of the employee being tested.
(b) SSN or Employee ID No.
(c) Laboratory name and address (can be pre-printed on the CCF).
(d) Employer name, address, phone number, and fax number (can be pre-printed on the CCF at Step 1-A).
(e) DER information required at § 40.36.
(f) MRO name, address, phone number, and fax number (can be pre-printed on the CCF at Step 1-B).
(g) The DOT Agency which regulates the employee's safety-sensitive duties (the checkmark can pre-printed in the appropriate box on the CCF at Step 1-D).
(h) Test reason, as appropriate: Pre-employment; Random; Reasonable Suspicion/Reasonable Cause; Post-Accident; Return-to-Duty; and Follow-up.
(i) Whether the test is to be observed or not (see § 40.67 of this part).
(j) (Optional) C/TPA name, address, phone, and fax number (can be pre-printed on the CCF).
(k) Specimen type to be collected ( i.e., oral fluid or urine).
§ 40.15   May an employer use a service agent to meet DOT drug and alcohol testing requirements?
(a) As an employer, you may use a service agent to perform the tasks needed to comply with this part and DOT agency drug and alcohol testing regulations, consistent with the requirements of Subpart Q and other applicable provisions of this part.
(b) As an employer, you are responsible for ensuring that the service agents you use meet the qualifications set forth in this part ( e.g., § 40.121 for MROs). You may require service agents to show you documentation that they meet the requirements of this part ( e.g., documentation of MRO qualifications required by § 40.121(e)).
(c) You remain responsible for compliance with all applicable requirements of this part and other DOT drug and alcohol testing regulations, even when you use a service agent. If you violate this part or other DOT drug and alcohol testing regulations because a service agent has not provided services as our rules require, a DOT agency can subject you to sanctions. Your good faith use of a service agent is not a defense in an enforcement action initiated by a DOT agency in which your alleged noncompliance with this part or a DOT agency drug and alcohol regulation may have resulted from the service agent's conduct.
(d) As an employer, you must not permit a service agent to act as your DER.
§ 40.17   Is an employer responsible for obtaining information from its service agents?
Yes, as an employer, you are responsible for obtaining information required by this part from your service agents. This is true whether or not you choose to use a C/TPA as an intermediary in transmitting information to you. For example, suppose an applicant for a safety-sensitive job takes a pre-employment drug test, but there is a significant delay in your receipt of the test result from an MRO or C/TPA. You must not assume that “no news is good news” and permit the applicant to perform safety-sensitive duties before receiving the result. This is a violation of the Department's regulations.
§ 40.19   [Reserved]
§ 40.21   May an employer stand down an employee before the MRO has completed the verification process?
(a) As an employer, you are prohibited from standing employees down, except consistent with a waiver a DOT agency grants under this section.
(b) You may make a request to the concerned DOT agency for a waiver from the prohibition of paragraph (a) of this section. Such a waiver, if granted, permits you to stand an employee down following the MRO's receipt of a laboratory report of a confirmed positive test for a drug or drug metabolite, an adulterated test, or a substituted test pertaining to the employee.
(1) For this purpose, the concerned DOT agency is the one whose drug and alcohol testing rules apply to the majority of the covered employees in your organization. The concerned DOT agency uses its applicable procedures for considering requests for waivers.
(2) Before taking action on a waiver request, the concerned DOT agency coordinates with other DOT agencies that regulate the employer's other covered employees.
(3) The concerned DOT agency provides a written response to each employer that petitions for a waiver, setting forth the reasons for the agency's decision on the waiver request.
(c) Your request for a waiver must include, as a minimum, the following elements:
(1) Information about your organization:
(i) Your determination that standing employees down is necessary for safety in your organization and a statement of your basis for it, including any data on safety problems or incidents that could have been prevented if a stand-down procedure had been in place;
(ii) Data showing the number of confirmed laboratory positive, adulterated, and substituted test results for your employees over the two calendar years preceding your waiver request, and the number and percentage of those test results that were verified positive, adulterated, or substituted by the MRO;
(iii) Information about the work situation of the employees subject to stand-down, including a description of the size and organization of the unit(s) in which the employees work, the process through which employees will be informed of the stand-down, whether there is an in-house MRO, and whether your organization has a medical disqualification or stand-down policy for employees in situations other than drug and alcohol testing; and
(iv) A statement of which DOT agencies regulate your employees.
(2) Your proposed written company policy concerning stand-down, which must include the following elements:
(i) Your assurance that you will distribute copies of your written policy to all employees that it covers;
(ii) Your means of ensuring that no information about the confirmed positive, adulterated, or substituted test result or the reason for the employee's temporary removal from performance of safety-sensitive functions becomes available, directly or indirectly, to anyone in your organization (or subsequently to another employer) other than the employee, the MRO and the DER;
(iii) Your means of ensuring that all covered employees in a particular job category in your organization are treated the same way with respect to stand-down;
(iv) Your means of ensuring that a covered employee will be subject to stand-down only with respect to the actual performance of safety-sensitive duties;
(v) Your means of ensuring that you will not take any action adversely affecting the employee's pay and benefits pending the completion of the MRO's verification process. This includes continuing to pay the employee during the period of the stand-down in the same way you would have paid him or her had he or she not been stood down;
(vi) Your means of ensuring that the verification process will commence no later than the time an employee is temporarily removed from the performance of safety-sensitive functions and that the period of stand-down for any employee will not exceed five days, unless you are informed in writing by the MRO that a longer period is needed to complete the verification process; and
(vii) Your means of ensuring that, in the event that the MRO verifies the test negative or cancels it—
(A) You return the employee immediately to the performance of safety-sensitive duties;
(B) The employee suffers no adverse personnel or financial consequences as a result;
(C) For a verified negative result, the employee will not be required to submit an alternate specimen for the same testing action. For a cancelled result, the employee could be required to submit an alternate specimen on a re-collection; and
(D) You maintain no individually identifiable record that the employee had a confirmed laboratory positive, adulterated, or substituted test result ( i.e., you maintain a record of the test only as a negative or cancelled test).
(d) The Administrator of the concerned DOT agency, or his or her designee, may grant a waiver request only if he or she determines that, in the context of your organization, there is a high probability that the procedures you propose will effectively enhance safety and protect the interests of employees in fairness and confidentiality.
(1) The Administrator, or his or her designee, may impose any conditions he or she deems appropriate on the grant of a waiver.
(2) The Administrator, or his or her designee, may immediately suspend or revoke the waiver if he or she determines that you have failed to protect effectively the interests of employees in fairness and confidentiality, that you have failed to comply with the requirements of this section, or that you have failed to comply with any other conditions the DOT agency has attached to the waiver.
(e) You must not stand employees down in the absence of a waiver, or inconsistent with the terms of your waiver. If you do, you are in violation of this part and DOT agency drug testing regulations, and you are subject to enforcement action by the DOT agency just as you are for other violations of this part and DOT agency rules.
§ 40.23   What actions do employers take after receiving verified test results?
(a) As an employer who receives a verified positive drug test result, you must immediately remove the employee involved from performing safety-sensitive functions. You must take this action upon receiving the initial report of the verified positive test result. Do not wait to receive the written report or the result of a split specimen test.
(b) As an employer who receives a verified adulterated or substituted drug test result, you must consider this a refusal to test and immediately remove the employee involved from performing safety-sensitive functions. You must take this action on receiving the initial report of the verified adulterated or substituted test result. Do not wait to receive the written report or the result of a split specimen test.
(c) As an employer who receives an alcohol test result of 0.04 or higher, you must immediately remove the employee involved from performing safety-sensitive functions. If you receive an alcohol test result of 0.02-0.039, you must temporarily remove the employee involved from performing safety-sensitive functions, as provided in applicable DOT agency regulations. Do not wait to receive the written report of the result of the test.
(d) As an employer, when an employee has a verified positive, adulterated, or substituted test result, or has otherwise violated a DOT agency drug and alcohol regulation, you must not return the employee to the performance of safety-sensitive functions until or unless the employee successfully completes the return-to-duty process of Subpart O of this part.
(e) As an employer who receives a drug test result indicating that the employee's specimen was dilute, take action as provided in § 40.197.
(f) As an employer who receives a drug test result indicating that the employee's test was cancelled because it was invalid and that a second collection must take place under direct observation—
(1) You must immediately direct the employee to provide a new specimen under direct observation (either an oral fluid specimen or a urine specimen under direct observation).
(2) You must not attach consequences to the finding that the test was invalid other than collecting a new specimen under direct observation.
(3) You must not give any advance notice of this test requirement to the employee.
(4) You must instruct the collector to note on the CCF the same reason ( e.g., random test, post-accident test) and DOT Agency (e.g., check DOT and FMCSA) as for the original collection.
(5) You must ensure that the collector conducts the collection under direct observation (either an oral fluid specimen or a urine specimen under direct observation).
(g) As an employer who receives a cancelled test result when a negative result is required ( e.g., pre-employment, return-to-duty, or follow-up test), you must direct the employee to provide another specimen immediately.
(h) As an employer, you may also be required to take additional actions required by DOT agency regulations ( e.g., FAA rules require some positive drug tests to be reported to the Federal Air Surgeon).
(i) As an employer, you must not alter a drug or alcohol test result transmitted to you by an MRO, BAT, or C/TPA.
§ 40.25   Must an employer check on the drug and alcohol testing record of employees it is intending to use to perform safety-sensitive duties?
(a)(1) Yes, as an employer, you must, after obtaining an employee's written consent, request the information about the employee listed in paragraphs (b) through (j) of this section. This requirement applies only to employees seeking to begin performing safety-sensitive duties for you for the first time ( i.e., a new hire, an employee transferring into a safety-sensitive position). If the employee refuses to provide this written consent, you must not permit the employee to perform safety-sensitive functions.
(2) If you are an employer regulated by FMCSA, you must comply with the requirements of this section by using the FMCSA's Drug and Alcohol Clearinghouse in accordance with 49 CFR 382.71(a). In addition, you must continue to comply with the requirements of this § 40.25 when checking an employee's testing history with employers regulated by a DOT operating administration other than FMCSA.
(3) If you are an employer regulated by FMCSA, with a prospective employee subject to drug and alcohol testing with a DOT agency other than FMCSA, you must continue to request the information about the employee listed in paragraphs (b) through (j) of this section. For example, if you are an employer regulated by both FMCSA and PHMSA, and you are hiring an employee to perform functions regulated by both DOT agencies, then you must query FMCSA's Clearinghouse to satisfy FMCSA's requirements and you must request the information listed in paragraphs (b) through (j) of this section to satisfy PHMSA's requirements.
(b) You must request the information listed in this paragraph (b) from DOT-regulated employers who have employed the employee during any period during the two years before the date of the employee's application or transfer:
(1) Alcohol tests with a result of 0.04 or higher alcohol concentration;
(2) Verified positive drug tests;
(3) Refusals to be tested (including verified adulterated or substituted drug test results);
(4) Other violations of DOT agency drug and alcohol testing regulations; and
(5) With respect to any employee who violated a DOT drug and alcohol regulation, documentation of the employee's successful completion of DOT return-to-duty requirements (including follow-up tests). If the previous employer does not have information about the return-do-duty process ( e.g., an employer who did not hire an employee who tested positive on a pre-employment test), you must seek to obtain this information from the employee.
(c) The information obtained from a previous employer includes any drug or alcohol test information obtained from previous employers under this section or other applicable DOT agency regulations.
(d) If feasible, you must obtain and review this information before the employee first performs safety-sensitive functions. If this is not feasible, you must obtain and review the information as soon as possible. However, you must not permit the employee to perform safety-sensitive functions after 30 days from the date on which the employee first performed safety-sensitive functions, unless you have obtained or made and documented a good faith effort to obtain this information.
(e) If you obtain information that the employee has violated a DOT agency drug and alcohol regulation, you must not use the employee to perform safety-sensitive functions unless you also obtain information that the employee has subsequently complied with the return-to-duty requirements of Subpart O of this part and DOT agency drug and alcohol regulations.
(f) You must provide to each of the employers from whom you request information under paragraph (b) of this section written consent for the release of the information cited in paragraph (a) of this section.
(g) The release of information under this section must be in any written form ( e.g., fax, e-mail, letter) that ensures confidentiality. As the previous employer, you must maintain a written record of the information released, including the date, the party to whom it was released, and a summary of the information provided.
(h) If you are an employer from whom information is requested under paragraph (b) of this section, you must, after reviewing the employee's specific, written consent, immediately release the requested information to the employer making the inquiry.
(i) As the employer requesting the information required under this section, you must maintain a written, confidential record of the information you obtain or of the good faith efforts you made to obtain the information. You must retain this information for three years from the date of the employee's first performance of safety-sensitive duties for you.
(j) As the employer, you must also ask the employee whether he or she has tested positive, or refused to test, on any pre-employment drug or alcohol test administered by an employer to which the employee applied for, but did not obtain, safety-sensitive transportation work covered by DOT agency drug and alcohol testing rules during the past two years. If the employee admits that he or she had a positive test or a refusal to test, you must not use the employee to perform safety-sensitive functions for you, until and unless the employee documents successful completion of the return-to-duty process (see paragraphs (b)(5) and (e) of this section).
§ 40.26   What form must an employer use to report Management Information System (MIS) data to a DOT agency?
As an employer, when you are required to report MIS data to a DOT agency, you must use the U.S. Department of Transportation Drug and Alcohol Testing MIS Data Collection Form to report that data. You must use the form and instructions referenced at appendix J to part 40. You must submit the MIS report in accordance with rule requirements ( e.g., dates for submission; selection of companies required to submit, and method of reporting) established by the DOT agency regulating your operation.
§ 40.27   May an employer require an employee to sign a consent or release in connection with the DOT drug and alcohol testing program?
No, as an employer, you must not require an employee to sign a consent, release, waiver of liability, or indemnification agreement with respect to any part of the drug or alcohol testing process covered by this part (including, but not limited to, collections, laboratory testing, MRO and SAP services).
§ 40.31   Who may collect specimens for DOT drug testing?
(a) Collectors meeting the requirements of this subpart are the only persons authorized to collect urine specimens for DOT drug testing.
(b) A urine collector must meet training requirements of § 40.33.
(c) An oral fluid collector must meet the training requirements of § 40.35.
(d) To avoid the appearance of a conflict of interest, if you are the immediate supervisor of the employee being tested, you must not act as the collector when that employee is tested, unless no other collector is available and you are permitted to do so under DOT agency drug and alcohol regulations.
(e) You must not act as the collector for the employee being tested if you work for a HHS-certified laboratory ( e.g., as a technician or accessioner) and could link the employee with a urine specimen, drug testing result, or laboratory report.
(f) Employees are not permitted to be their own collector.
(1) An employee who is a qualified collector is not permitted to be their own collector; another qualified collector must perform the collection in accordance with this part.
(2) To avoid a potential conflict of interest, a collector must not be related to the employee being tested ( e.g., spouse, ex-spouse, relative) or a close personal friend.
§ 40.33   What training requirements must a collector meet for urine collection?
To be permitted to act as a urine collector in the DOT drug testing program, you must meet each of the requirements of this section:
(a) Basic information. You must be knowledgeable about this part, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency regulations applicable to the employers for whom you perform collections. DOT agency regulations, the DOT Urine Specimen Collection Procedures Guidelines, and other materials are available from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE., Washington DC, 20590, 202-366-3784, or on the ODAPC Web site ( https://www.transportation.gov/odapc ). You must keep current on any changes to these materials. You must subscribe to the ODAPC list-serve at: https://www.transportation.gov/odapc/get-odapc-email-updates.
(b) Qualification training. You must receive qualification training meeting the requirements of this paragraph. Qualification training must provide instruction on the following subjects:
(1) All steps necessary to complete a collection correctly and the proper completion and transmission of the CCF;
(2) “Problem” collections ( e.g., situations like “shy bladder” and attempts to tamper with a specimen);
(3) Fatal flaws, correctable flaws, and how to correct problems in collections; and
(4) The collector's responsibility for maintaining the integrity of the collection process, ensuring the privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate;
(c) Initial Proficiency Demonstration. Following your completion of qualification training under paragraph (b) of this section, you must demonstrate proficiency in collections under this part by completing five consecutive error-free mock collections.
(1) The five mock collections must include two uneventful collection scenarios, one insufficient quantity of urine scenario, one temperature out of range scenario, and one scenario in which the employee refuses to sign the CCF and initial the specimen bottle tamper-evident seal.
(2) Another person must monitor and evaluate your performance, in person or by a means that provides real-time observation and interaction between the instructor and trainee, and attest in writing that the mock collections are “error-free.” This person must be a qualified urine collector who has demonstrated necessary knowledge, skills, and abilities by—
(i) Regularly conducting DOT urine drug test collections for a period of at least one year;
(ii) Conducting urine collector training under this part for at least one year; or
(iii) Successfully completing a urine “train the trainer” course.
(d) You must meet the requirements of paragraphs (b) and (c) of this section before you begin to perform collector functions.
(e) Refresher training. No less frequently than every five years from the date on which you satisfactorily complete the requirements of paragraphs (b) and (c) of this section, you must complete refresher training that meets all the requirements of paragraphs (b) and (c) of this section.
(f) Error correction training. If you make a mistake in the collection process that causes a test to be cancelled ( i.e., a fatal or uncorrected flaw), you must undergo error correction training. This training must occur within 30 days of the date you are notified of the error that led to the need for retraining. Errors that cause cancellation but occur outside the collection process ( e.g., when a specimen is crushed or otherwise damaged during the transportation process, or is lost in transit), the cancellation would not be the result of an error by the collector during the collection process and does not require the collector to be retrained.
(1) Error correction training must be provided and your proficiency documented in writing by a person who meets the requirements of paragraph (c)(2) of this section.
(2) Error correction training is required to cover only the subject matter area(s) in which the error that caused the test to be cancelled occurred.
(3) As part of the error correction training, you must demonstrate your proficiency in the collection procedures of this part by completing three consecutive error-free mock collections. The mock collections must include one uneventful scenario and two scenarios related to the area(s) in which your error(s) occurred. The person providing the training must monitor and evaluate your performance and attest in writing that the mock collections were “error-free.”
(g) Documentation. You must maintain documentation showing that you currently meet all requirements of this section. You must provide this documentation on request to DOT agency representatives and to employers and C/TPAs who are using or negotiating to use your services.
§ 40.35   What training requirements must a collector meet for oral fluid collection?
To be permitted to act as an oral fluid collector in the DOT drug testing program, you must meet each of the requirements of this section:
(a) Basic information. You must be knowledgeable about this part, the current “DOT Oral Fluid Specimen Collection Procedures Guidelines,” and DOT agency regulations applicable to the employers for whom you perform collections. DOT agency regulations, guidelines, and other materials are available from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE, Washington DC, 20590, 202-366-3784, or on the ODAPC website ( https://www.transportation.gov/odapc ). You must keep current on any changes to these materials. You must subscribe to the ODAPC list-serve at: https://www.transportation.gov/odapc/get-odapc-email-updates.
(b) Qualification training. You must receive qualification training meeting the requirements of this paragraph (b). Qualification training must provide instruction on the following subjects:
(1) Training on the testing procedures of this part;
(2) Training to proficiency in the operation of the particular oral fluid collection device(s) you will be using.
(3) All steps necessary to complete a collection correctly and the proper completion and transmission of the CCF;
(4) “Problem” collections ( e.g., situations like “dry mouth” and attempts to tamper with a specimen);
(5) Fatal flaws, correctable flaws, and how to correct problems in collections; and
(6) The collector's responsibility for maintaining the integrity of the collection process, ensuring the privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate.
(c) Initial proficiency demonstration. Following your completion of qualification training under paragraph (b) of this section, you must demonstrate proficiency in collections under this part by completing five consecutive error-free mock collections for each device you will use.
(1) The five mock collections for each device must include one uneventful collection scenario, one insufficient specimen quantity scenario; one scenario in which the employee has something in their mouth that might interfere with the collection; one scenario in which the employee attempts to tamper with the specimen; and one scenario in which the employee refuses to sign the CCF. For each of the five mock collections, the collector must check the expiration date of the device, show it to the employee, and record the date on the CCF used. The collector must ensure, when applying the labels, they do not cover the expiration dates.
(2) Another person must monitor and evaluate your performance, in person or by a means that provides real-time observation and interaction between you and the qualified collector, who must attest in writing that the mock collections are “error-free.” Except as provided in paragraph (c)(3) of this section, this person must be a qualified oral fluid collector who has demonstrated necessary knowledge, skills, and abilities by—
(i) Regularly conducting DOT oral fluid drug test collections for a period of at least one year;
(ii) Conducting oral fluid collector training under this part for at least one year; or
(iii) Successfully completing an oral fluid “train the trainer” course.
(3) As the person monitoring and evaluating the collector's five mock collections pursuant to paragraphs (c)(1) and (2) of this section, you need not be a qualified oral fluid collector to do so if you meet the necessary knowledge, skills, and abilities in paragraph (c)(2)(ii) or (iii) until otherwise specified (one year after HHS publishes a Federal Register notification of the first certified oral fluid drug testing laboratory (HHS notification)). Furthermore, the one-year requirement in paragraph (c)(2)(ii) is not applicable until otherwise specified (one year after the HHS notification).
(d) Schedule for qualification training and initial proficiency demonstration. You must meet the requirements of paragraphs (b) and (c) of this section before you begin to perform collector functions.
(e) Refresher training. No less frequently than every five years from the date on which you satisfactorily complete the requirements of paragraphs (b) and (c) of this section, you must complete refresher training that meets all the requirements of paragraphs (b) and (c).
(f) Error correction training. If you make a mistake in the collection process that causes a test to be cancelled ( i.e., a fatal or uncorrected flaw), you must undergo error correction training. This training must occur within 30 days of the date you are notified of the error that led to the need for retraining.
(1) Error correction training must be provided and your proficiency documented in writing by a person who meets the requirements of paragraph (c)(2) of this section.
(2) Error correction training is required to cover only the subject matter area(s) in which the error that caused the test to be cancelled occurred.
(3) As part of the error correction training, you must demonstrate your proficiency in the collection procedures of this part by completing three consecutive error-free mock collections. The mock collections must include one uneventful scenario and two scenarios related to the area(s) in which your error(s) occurred. The person providing the training must monitor and evaluate your performance and attest in writing that the mock collections were “error-free.”
(g) Documentation. You must maintain documentation showing that you currently meet all requirements of this section. You must provide this documentation on request to DOT agency representatives and to employers and C/TPAs who are using or negotiating to use your services.
§ 40.36   What information about the DER must employers provide to collectors?
As an employer, you must provide to collectors the name and telephone number of the appropriate DER (and C/TPA, where applicable) to contact about any problems or issues that may arise during the testing process.
§ 40.40   What form is used to document a DOT collection?
(a) The Federal Drug Testing Custody and Control Form (CCF) must be used to document every collection required by the DOT drug testing program. You may view this form on the Department's website ( https://www.transportation.gov/odapc ) or the HHS website ( https://www.workplace.samhsa.gov ).
(b) You must not use a non-Federal form or an expired CCF to conduct a DOT collection. As a laboratory, C/TPA or other party that provides CCFs to employers, collection sites, or other customers, you must not provide copies of an expired CCF to these participants. You must also affirmatively notify these participants that they must not use an expired CCF.
(c) As a participant in the DOT drug testing program, you are not permitted to modify or revise the CCF except as follows:
(1) You may include, in the area outside the border of the form, other information needed for billing or other purposes necessary to the collection process.
(2) The CCF must include the names, addresses, telephone numbers and any other appropriate contact information ( e.g., an email address of the employer and the MRO), including the DER's name and contact information. All of this information must be preprinted, typed, or handwritten. Fax numbers may be included but are not required. The MRO information must include the physician's name and address, as opposed to only a generic clinic, health care organization, company name, or post office box. This information is required, and an employer, collector, service agent or any other party is prohibited from omitting it. In addition, a C/TPA's name, address, telephone and fax numbers, and any other appropriate contact information should be included, but is not required. The employer may use a C/TPA's address in place of its own, but must continue to include its name, telephone and fax numbers, and any other appropriate contact information.
(3) As an employer you may preprint the box in Step 1-D of the CCF for the DOT agency under whose authority the test will occur.
(4) As a collector, you may use a CCF with your name, address, telephone number, and fax number preprinted, but under no circumstances may you sign the form before the collection event. If a collection takes place at a clinic, the actual address of the clinic should be used, not a corporate address of the collection company. If the collection takes place onsite at the employer, the employer's address must be noted as the collection site address. If the collection takes place in a “mobile unit” or at an accident site, the collector must enter the actual location address of the collection or as near an approximation as possible. The collector must ensure that the required collector telephone number is the number that the laboratory, MRO, or employer may use to directly contact the individual collector and/or the collector's supervisor during the collection site's business hours. The collector must not provide a number for a call center.
(5) When using an electronic CCF, you must establish adequate confidentiality and security measures to ensure that confidential employee records are not available to unauthorized persons. This includes protecting the physical security of records, access controls, and computer security measures to safeguard confidential data in electronic form.
(d) Under no circumstances may the CCF transmit personal identifying information about an employee (other than a SSN or Employee ID No.) to a laboratory.
(e) As an employer, you may use an equivalent foreign-language version of the CCF approved by ODAPC. You may use such a non-English language form only in a situation where both the employee and collector understand and can use the form in that language.
(f) An employer who uses an electronic CCF must ensure that the collection site, the primary and split laboratories, and MRO have compatible systems, and that the employee and any other program participants in the testing process will receive a legible copy of the CCF.
§ 40.41   May employers use the CCF for non-Federal collections or non-Federal forms for DOT collections?
(a) No, as an employer, you are prohibited from using the CCF for non-Federal collections. You are also prohibited from using non-Federal forms for DOT collections. Doing either subjects you to enforcement action under DOT agency regulations.
(b) (1) In the rare case where the collector, either by mistake or as the only means to conduct a test under difficult circumstances ( e.g., post-accident or reasonable suspicion test with insufficient time to obtain the CCF), uses a non-Federal form for a DOT collection, the use of a non-Federal form does not present a reason for the laboratory to reject the specimen for testing or for an MRO to cancel the result.
(2) The use of the non-Federal form is a “correctable flaw.” As an MRO, to correct the problem you must follow the procedures of § 40.205(b)(2).
§ 40.42   Where does a urine collection for a DOT drug test take place?
(a) A urine collection for a DOT drug test must take place in a collection site meeting the requirements of this section.
(b) If you are operating a collection site, you must ensure that it meets the security requirements of § 40.43.
(c) If you are operating a collection site, you must have all necessary personnel, materials, equipment, facilities and supervision to provide for the collection, temporary storage, and shipping of urine specimens to a laboratory, and a suitable clean surface for writing.
(d) Your collection site must include a facility for urination described in either paragraph (e) or paragraph (f) of this section.
(e) The first, and preferred, type of facility for urination that a collection site may include is a single-toilet room, having a full-length privacy door, within which urination can occur.
(1) No one but the employee may be present in the room during the collection, except for the observer in the event of a directly observed collection.
(2) You must have a source of water for washing hands, that, if practicable, should be external to the closed room where urination occurs. If an external source is not available, you may meet this requirement by securing all sources of water and other substances that could be used for adulteration and substitution ( e.g., water faucets, soap dispensers) and providing moist towelettes outside the closed room.
(f) The second type of facility for urination that a collection site may include is a multistall restroom.
(1) Such a site must provide substantial visual privacy ( e.g., a toilet stall with a partial-length door) and meet all other applicable requirements of this section.
(2) If you use a multi-stall restroom, you must either—
(i) Secure all sources of water and other substances that could be used for adulteration and substitution ( e.g., water faucets, soap dispensers) and place bluing agent in all toilets or secure the toilets to prevent access; or
(ii) Conduct all collections in the facility as monitored collections (see § 40.69 for procedures). This is the only circumstance in which you may conduct a monitored collection.
(3) No one but the employee may be present in the multistall restroom during the collection, except for the monitor in the event of a monitored collection or the observer in the event of a directly observed collection.
(g) A collection site may be in a medical facility, a mobile facility ( e.g., a van), a dedicated collection facility, or any other location meeting the requirements of this section.
§ 40.43   What steps must operators of collection sites and collectors take to protect the security and integrity of urine collections?
(a) Collectors and operators of collection sites must take the steps listed in this section to prevent unauthorized access that could compromise the integrity of collections.
(b) As a collector, you must do the following before each collection to deter tampering with specimens:
(1) Secure any water sources or otherwise make them unavailable to employees ( e.g., turn off water inlet, tape handles to prevent opening faucets);
(2) Ensure that the water in the toilet is blue;
(3) Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present;
(4) Inspect the site to ensure that no foreign or unauthorized substances are present;
(5) Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank;
(6) Ensure that undetected access ( e.g., through a door not in your view) is not possible;
(7) Secure areas and items ( e.g., ledges, trash receptacles, paper towel holders, under-sink areas) that appear suitable for concealing contaminants; and
(8) Recheck items in paragraphs (b)(1) through (7) of this section following each collection to ensure the site's continued integrity.
(c) If the collection site uses a facility normally used for other purposes, like a public rest room or hospital examining room, you must, as a collector, also ensure before the collection that:
(1) Access to collection materials and specimens is effectively restricted; and
(2) The facility is secured against access during the procedure to ensure privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted.
(d) As a collector, you must take the following additional steps to ensure security during the collection process:
(1) To avoid distraction that could compromise security, you are limited to conducting a collection for only one employee at a time. However, during the time one employee is in the period for drinking fluids in a “shy bladder” situation (see § 40.193(b)), you may conduct a collection for another employee.
(2) To the greatest extent you can, keep an employee's collection container within view of both you and the employee between the time the employee has urinated and the specimen is sealed.
(3) Ensure you are the only person in addition to the employee who handles the specimen before it is poured into the bottles and sealed with tamper-evident seals.
(4) In the time between when the employee gives you the specimen and when you seal the specimen, remain within the collection site.
(5) Maintain personal control over each specimen and CCF throughout the collection process.
(e) If you are operating a collection site, you must implement a policy and procedures to prevent unauthorized personnel from entering any part of the site in which urine specimens are collected or stored.
(1) Only employees being tested, collectors and other collection site workers, DERs, employee and employer representatives authorized by the employer ( e.g., employer policy, collective bargaining agreement), and DOT agency representatives are authorized persons for purposes of this paragraph (e).
(2) Except for the observer in a directly observed collection or the monitor in the case of a monitored collection, you must not permit anyone to enter the urination facility in which employees provide specimens.
(3) You must ensure that all authorized persons are under the supervision of a collector at all times when permitted into the site.
(4) You or the collector may remove any person who obstructs, interferes with, or causes a delay in the collection process.
(f) If you are operating a collection site, you must minimize the number of persons handling specimens.
§ 40.44   What materials are used to collect urine specimens?
For each DOT drug test, you must use a collection kit meeting the requirements of Appendix A of this part.
§ 40.45   What materials are used to send urine specimens to the laboratory?
(a) Except as provided in paragraph (b) of this section, you must use a shipping container that adequately protects the specimen bottles from shipment damage in the transport of specimens from the collection site to the laboratory.
(b) You are not required to use a shipping container if a laboratory courier hand-delivers the specimens from the collection site to the laboratory.
§ 40.47   Where does an oral fluid collection for a DOT drug test take place?
(a) An oral fluid collection for a DOT drug test must take place in a collection site meeting the requirements of this section.
(b) If you are operating an oral fluid collection site:
(1) You must ensure that it meets the security requirements of § 40.48;
(2) The site may be a permanent or temporary facility located either at the work site or at a remote site;
(3) The site may be in a medical facility, a mobile facility ( e.g., a van), a dedicated collection facility, or any other location meeting the requirements of this section; and
(4) You must have all necessary personnel, materials, equipment, and facilities that include privacy and supervision to provide for the collection, temporary storage, and shipping of specimens to a laboratory, and a suitable clean surface for writing.
(c) If a collection site is not accessible and there is an immediate requirement to collect an oral fluid specimen ( e.g., an accident investigation), another site may be used for the collection, if the collection is performed by a collector who has been trained to collect oral fluid specimens in accordance with this part and the manufacturer's procedures for the collection device.
§ 40.48   What steps must operators of collection sites and collectors take to protect the security and integrity of oral fluid collections?
(a) Collectors and operators of collection sites must take the steps listed in this section to prevent unauthorized access that could compromise the integrity of collections.
(b) As a collector, you must do the following before each collection to deter tampering with specimens:
(1) Ensure that access to collection materials and specimens is effectively restricted;
(2) Ensure that undetected access ( e.g., through a door not in your view) is not possible; and
(3) Ensure the security of the facility during the collection process to maintain privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted.
(c) As a collector, you must take the following additional steps to ensure security during the collection process:
(1) To avoid distraction that could compromise security, you are limited to conducting a collection for only one employee at a time. However, during the time one employee is in the period for drinking fluids in a “dry mouth” situation ( see § 40.72(b)(1)), you may conduct a collection for another employee as long as the employee with “dry mouth” remains supervised.
(2) To the greatest extent practicable, keep an employee's collection container within view of both you and the employee between the time the employee has provided the oral fluid specimen and the specimen is sealed.
(3) Ensure you are the only person in addition to the employee who handles the specimen before it is sealed with tamper-evident seals.
(4) In the time between when the employee gives you the specimen and when you seal the specimen, remain within the collection site.
(5) Maintain personal control over each specimen and CCF throughout the collection process.
(d) If you are operating a collection site, you must implement a policy and procedures to prevent unauthorized personnel from entering any part of the site in which oral fluid specimens are collected or stored.
(1) Only employees being tested, collectors and other collection site workers, DERs, employee and employer representatives authorized by the employer ( e.g., employer policy, collective bargaining agreement), and DOT agency representatives are authorized persons for purposes of this paragraph (d).
(2) You must ensure that all authorized persons are under the supervision of a collector at all times when permitted into the site.
(3) You or the collector may remove any person who obstructs, interferes with, or causes a delay in the collection process.
(e) If you are operating a collection site, you must minimize the number of persons handling specimens.
§ 40.49   What materials are used to collect oral fluid specimens?
For each DOT drug test, you must use a collection device meeting the requirements of appendix B of this part.
§ 40.51   What materials are used to send oral fluid specimens to the laboratory?
(a) Except as provided in paragraph (b) of this section, you must use a shipping container that adequately protects the specimen bottles from damage in the transport of specimens from the collection site to the laboratory.
(b) You are not required to use a shipping container if a laboratory courier hand-delivers the specimens from the collection site to the laboratory.
§ 40.61   What are the preliminary steps in the drug testing collection process?
As the collector, you must take the following steps before actually beginning a collection:
(a) When a specific time for an employee's test has been scheduled, or the collection site is at the employee's work site, and the employee does not appear at the collection site at the scheduled time, contact the DER to determine the appropriate interval within which the DER has determined the employee is authorized to arrive. If the employee's arrival is delayed beyond that time, you must notify the DER that the employee has not reported for testing, the DER must determine whether the employee has refused to test ( see §§ 40.191(a)(1) and 40.355(i)). In a situation where a C/TPA has notified an owner/operator or other individual employee to report for testing (other than for a pre-employment test) and the employee does not appear, the C/TPA must determine whether the employee has refused to test ( see §§ 40.191(a)(1) and 40.355(j)).
(b) Ensure that, when the employee enters the collection site, you begin the testing process without undue delay. For example, you must not wait because the employee says he or she is not ready or is unable to urinate or because an authorized employer or employee representative is delayed in arriving.
(1) If the employee is also going to take a DOT alcohol test, you must ensure, to the greatest extent practicable, that the alcohol test is completed before the drug testing collection process begins.
(2) If the employee needs medical attention ( e.g., an injured employee in an emergency medical facility who is required to have a post-accident test), do not delay this treatment to collect a specimen.
(3) You must not collect a specimen from an unconscious employee to conduct a drug test under this part.
(4) You must not catheterize a conscious employee for purposes of a urine test. However, you must inform an employee who normally voids through self-catheterization that the employee is required to provide a specimen in that manner. If an employee normally voids through self-catheterization, but declines to do so for the urine test, the collector should notify the DER of the circumstances, so that the actual employer can determine whether the situation constitutes a refusal to test by the employee.
(c) Require the employee to provide positive identification. You must see a photo ID issued by the employer (other than in the case of an owner-operator or other self-employed individual) or a Federal, state, or local government ( e.g., a driver's license). You may not accept faxes or photocopies of identification. Positive identification by an employer representative (not a co-worker or another employee being tested) is also acceptable. If the employee cannot produce positive identification, you must contact a DER to verify the identity of the employee.
(d) If the employee asks, provide your identification to the employee. Your identification must include your name and your employer's name, but does not have to include your picture, address, or telephone number.
(e) Explain the basic collection procedure to the employee, and notify the employee that instructions for completing the CCF can be found at the HHS ( https://www.samhsa.gov/workplace ) and DOT ( https://www.transportation.gov/odapc ) websites.
(f) Direct the employee to remove outer clothing ( e.g., coveralls, jacket, coat, hat) that could be used to conceal items or substances that could be used to tamper with a specimen. You must also direct the employee to leave these garments and any briefcase, purse, or other personal belongings with you or in a mutually agreeable location. You must advise the employee that failure to comply with your directions constitutes a refusal to test.
(1) If the employee asks for a receipt for any belongings left with you, you must provide one.
(2) You must allow the employee to keep his or her wallet.
(3) You must not ask the employee to remove other clothing ( e.g., shirts, pants, dresses, underwear), to remove all clothing, or to change into a hospital or examination gown (unless the urine collection is being accomplished simultaneously with a DOT agency-authorized medical examination).
(4) You must direct the employee to empty his or her pockets and display the items in them to ensure that no items are present which could be used to adulterate the specimen. If nothing is there that can be used to adulterate a specimen, the employee can place the items back into his or her pockets. As the employee, you must allow the collector to make this observation.
(5) If, in your duties under paragraph (f)(4) of this section, you find any material that could be used to tamper with a specimen, you must:
(i) Determine if the material appears to be brought to the collection site with the intent to alter the specimen, and, if it is, either conduct a directly observed urine collection using direct observation procedures ( see § 40.67) or an oral fluid specimen collection, make a note on the CCF and continue with collection process; or
(ii) Determine if the material appears to be inadvertently brought to the collection site ( e.g., eye drops), secure and maintain it until the collection process is completed and conduct a normal ( i.e., unobserved) collection.
(g) You must instruct the employee not to list medications that he or she is currently taking on the CCF. (The employee may make notes of medications on the back of the employee copy of the form for his or her own convenience, but these notes must not be transmitted to anyone else.)
§ 40.63   What steps does the collector take in the collection process before the employee provides a urine specimen?
As the collector, you must take the following steps before the employee provides the urine specimen:
(a) Ensure all items under Step 1 of the CCF are complete and accurate ( e.g., if Step 1.D is not checked, put a check mark for the “Specify DOT Agency” under the authority of which the test will take place; if the address where the collection is actually taking place is not in Step 1.G, update that.)
(b) Instruct the employee to wash and dry his or her hands at this time. You must tell the employee not to wash his or her hands again until after delivering the specimen to you. You must not give the employee any further access to water or other materials that could be used to adulterate or dilute a specimen.
(c) Select, or allow the employee to select, an individually wrapped or sealed collection container from collection kit materials. Either you or the employee, with both of you present, must unwrap or break the seal of the collection container. You must not unwrap or break the seal on any specimen bottle at this time. You must not allow the employee to take anything from the collection kit into the room used for urination except the collection container.
(d) Direct the employee to go into the room used for urination, provide a specimen of at least 45 mL, not flush the toilet, and return to you with the specimen as soon as the employee has completed the void.
(1) Except in the case of an observed or a monitored collection (see §§ 40.67 and 40.69), neither you nor anyone else may go into the room with the employee.
(2) As the collector, you may set a reasonable time limit for voiding.
(e) You must pay careful attention to the employee during the entire collection process to note any conduct that clearly indicates an attempt to tamper with a specimen ( e.g., substitute urine in plain view or an attempt to bring into the collection site an adulterant or urine substitute). If you detect such conduct, you must require that a collection take place immediately under direct observation ( see § 40.67) and complete Step 2 by noting the conduct in the “Remarks” line of the CCF and the fact that the collection was observed by checking the “Observed” box. You must also, as soon as possible, inform the DER and collection site supervisor that a collection took place under direct observation and the reason for doing so.
§ 40.65   What does the collector check for when the employee presents a urine specimen?
As a collector, you must check the following when the employee gives the collection container to you:
(a) Sufficiency of specimen. You must check to ensure that the specimen contains at least 45 mL of urine.
(1) If it does not, you must follow “shy bladder” procedures (see § 40.193(b)).
(2) When you follow “shy bladder” procedures, you must discard the original specimen, unless another problem ( i.e., temperature out of range, signs of tampering) also exists.
(3) You are never permitted to combine urine collected from separate voids to create a specimen.
(4) You must discard any excess urine.
(b) Temperature. You must check the temperature of the specimen no later than four minutes after the employee has given you the specimen.
(1) The acceptable temperature range is 32-38 °C/90-100 °F.
(2) You must determine the temperature of the specimen by reading the temperature strip attached to the collection container.
(3) If the specimen temperature is within the acceptable range, you must mark the “Yes” box on the CCF (Step 2).
(4) If the specimen temperature is outside the acceptable range, you must mark the “No” box and enter in the “Remarks” line (Step 2) your findings about the temperature.
(5) If the specimen temperature is outside the acceptable range, you must immediately conduct a new urine collection using direct observation procedures ( see § 40.67) or an oral fluid collection.
(6) In a case where a specimen is collected under direct observation because of the temperature being out of range, you must process both the original specimen and the specimen collected using direct observation (including oral fluid) and send the two sets of specimens to their respective laboratories. This is true even in a case in which the original specimen has insufficient volume and the temperature is out of range. You must also, as soon as possible, inform the DER and collection site supervisor that a collection took place under direct observation and the reason for doing so.
(7) In a case where the employee refuses to provide another specimen (see § 40.191(a)(3)) or refuses to provide another specimen under direct observation (see § 40.191(a)(4)), you must notify the DER. As soon as you have notified the DER, you must discard any specimen the employee has provided previously during the collection procedure.
(c) Signs of tampering. You must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering ( e.g., if you notice any unusual odor).
(1) If it is apparent from this inspection that the employee has tampered with the specimen ( e.g., blue dye in the specimen, excessive foaming when shaken, or smell of bleach), you must immediately conduct a new urine collection using direct observation procedures ( see § 40.67) or an oral fluid collection.
(2) In a case where a specimen is collected under direct observation because of showing signs of tampering, you must process both the original specimen and the specimen collected using direct observation and send the two sets of specimens to the laboratory. This is true even in a case in which the original specimen has insufficient volume but it shows signs of tampering. You must also, as soon as possible, inform the DER and collection site supervisor that a collection took place under direct observation and the reason for doing so.
(3) In a case where the employee refuses to provide a specimen under direct observation (see § 40.191(a)(4)), you must discard any specimen the employee provided previously during the collection procedure. Then you must notify the DER as soon as practicable.
§ 40.67   When and how is a directly observed urine collection conducted?
(a) As an employer, you must direct an immediate collection under direct observation with no advance notice to the employee, if:
(1) The laboratory reported to the MRO that a specimen is invalid, and the MRO reported to you that there was not an adequate medical explanation for the result;
(2) The MRO reported to you that the original positive, adulterated, or substituted result had to be cancelled because the test of the split specimen could not be performed; or
(3) The laboratory reported to the MRO that the specimen was negative-dilute with a creatinine concentration greater than or equal to 2 mg/dL but less than or equal to 5 mg/dL, and the MRO reported the specimen to you as negative-dilute and that a second collection must take place under direct observation (see § 40.197(b)(1)).
(4) You realize a collection under direct observation was required but was not conducted or the service agent informs you that a direct observation should have been collected but was not ( see paragraph (n) of this section).
(b) As an employer, you must direct a collection under direct observation of an employee if the drug test is a return-to-duty test or a follow-up test.
(c) As a collector, you must immediately conduct a collection under direct observation if:
(1) You are directed by the DER to do so (see paragraph (a) of this section); or
(2) You observed materials brought to the collection site or the employee's conduct clearly indicates an attempt to tamper with a specimen (see §§ 40.61(f)(5)(i) and 40.63(e)); or
(3) The temperature on the original specimen was out of range ( see § 40.65(b)(5));
(4) The original specimen appeared to have been tampered with ( see § 40.65(c)(1)); or
(5) The test reason is return-to-duty or follow-up.
(d)(1) As the employer, you must explain to the employee the reason for a directly observed collection under paragraph (a) or (b) of this section.
(2) As the collector, you must explain to the employee the reason, if known, under this part for a directly observed collection.
(e) As the collector, you must complete a new CCF for the directly observed collection.
(1) You must mark the “reason for test” block (Step 1) the same as for the first collection.
(2) You must check the “Observed, (Enter Remark)” box and enter the reason (see paragraphs (c)(2) through (4) of this section) in the “Remarks” line (Step 2).
(f) In a case where two sets of specimens are being sent to the laboratory because of suspected tampering with the specimen at the collection site, enter on the “Remarks” line of the CCF (Step 2) for each specimen a notation to this effect ( e.g., collection 1 of 2, or 2 of 2) and the specimen ID number of the other specimen.
(g) As the collector, you must ensure that the observer is the same gender as the employee.
(1) You must never permit an opposite gender person to act as the observer.
(2) The observer can be a different person from the collector and need not be a qualified collector.
(3) If a same gender collector cannot be found or in circumstances of nonbinary or transgender employees:
(i) If the employer has a standing order to allow oral fluid testing in such situations, the collector will follow that order;
(ii) If there is no standing order from the employer, the collector must contact the DER and either conduct an oral fluid test if the collection site is able to do so, or send the employee to a collection site acceptable to the employer for the oral fluid test.
(h) As the collector, if someone else is to observe the collection ( e.g., in order to ensure a same gender observer), you must verbally instruct that person to follow procedures at paragraphs (i) and (j) of this section. If you, the collector, are the observer, you too must follow these procedures.
(i) As the observer, you must request the employee to raise his or her shirt, blouse, or dress/skirt, as appropriate, above the waist; and lower clothing and underpants to show you, by turning around, that they do not have a prosthetic device. After you have determined that the employee does not have such a device, you may permit the employee to return clothing to its proper position for observed urination.
(j) As the observer, you must watch the employee urinate into the collection container. Specifically, you are to watch the urine go from the employee's body into the collection container.
(k) As the observer but not the collector, you must not take the collection container from the employee, but you must observe the specimen as the employee takes it to the collector.
(l) As the collector, when someone else has acted as the observer, you must include the observer's name in the “Remarks” line of the CCF (Step 2).
(m) As the employee, if you decline to allow a directly observed collection required or permitted under this section to occur, this is a refusal to test.
(n) As a service agent, when you learn that a directly observed collection should have been collected but was not, you must inform the employer that it must direct the employee to have an immediate recollection under direct observation.
§ 40.69   How is a monitored urine collection conducted?
(a) As stated in § 40.42(f)(2), if you are conducting a urine collection in a multi-stall restroom and you cannot secure all sources of water and other substances that could be used for adulteration and substitution, you must conduct a monitored collection. This is the only circumstance in which you must conduct a monitored collection.
(b) As the collector, you must secure the room being used for the monitored collection so that no one except the employee and the monitor can enter it until after the collection has been completed.
(c) As the collector, you must ensure that the monitor is the same gender as the employee, unless the monitor is a medical professional (e.g., nurse, doctor, physician's assistant, technologist, or technician licensed or certified to practice in the jurisdiction in which the collection takes place). The monitor can be a different person from the collector and need not be a qualified collector.
(d) As the collector, if someone else is to monitor the collection (e.g., in order to ensure a same-gender monitor), you must verbally instruct that person to follow the procedures of paragraphs (d) and (e) of this section. If you, the collector, are the monitor, you must follow these procedures.
(e) As the monitor, you must not watch the employee urinate into the collection container. If you hear sounds or make other observations indicating an attempt to tamper with a specimen, there must be an additional collection under direct observation. See §§ 40.63(e), 40.65(c), and 40.67(c)(2)(3)).
(f) As the monitor, you must ensure that the employee takes the collection container directly to the collector as soon as the employee has exited the enclosure.
(g) As the collector, when someone else has acted as the monitor, you must note that person's name in the “Remarks” line of the CCF (Step 2).
(h) As the employee being tested, if you decline to permit a collection authorized under this section to be monitored, it is a refusal to test.
§ 40.71   How does the collector prepare the urine specimen?
(a) All collections under DOT agency drug testing regulations must be split specimen collections.
(b) As the collector, you must take the following steps, in order, after the employee brings the urine specimen to you. You must take these steps in the presence of the employee.
(1) After the collection, check the box on the CCF (Step 2) indicating that this was a “Urine” and “Split” specimen collection.
(2) You, not the employee, must first pour at least 30 mL of urine from the collection container into one specimen bottle, to be used for the primary specimen.
(3) You, not the employee, must then pour at least 15 mL of urine from the collection container into the second specimen bottle to be used for the split specimen.
(4) You, not the employee, must place and secure ( i.e., tighten or snap) the lids/caps on the bottles.
(5) You, not the employee, must seal the bottles by placing the tamper-evident bottle seals over the bottle caps/lids and down the sides of the bottles.
(6) You, not the employee, must then write the date on the tamper-evident bottle seals.
(7) You must then ensure that the employee initials the tamper-evident bottle seals for the purpose of certifying that the bottles contain the specimens he or she provided. If the employee fails or refuses to do so, you must note this in the “Remarks” line of the CCF (Step 2) and complete the collection process.
(8) You must discard any urine left over in the collection container after both specimen bottles have been appropriately filled and sealed. There is one exception to this requirement: you may use excess urine to conduct clinical tests (e.g., protein, glucose) if the collection was conducted in conjunction with a physical examination required by a DOT agency regulation. Neither you nor anyone else may conduct further testing (such as adulteration testing) on this excess urine and the employee has no legal right to demand that the excess urine be turned over to the employee.
§ 40.72   What steps does the collector take in the collection process before the employee provides an oral fluid specimen?
(a) The collector requests that the employee open the employee's mouth, and the collector inspects the oral cavity to ensure that it is free of any items that could impede or interfere with the collection of an oral fluid specimen ( e.g., candy, gum, food, or tobacco) or could be used to adulterate, substitute, or alter the specimen.
(1) If the collector finds indication(s) of anything identified above, the collector will ask the employee to lift their tongue and/or separate their cheek from their gum to permit full inspection. If this occurs, the employee may cleanse his or her hands, but must not decline the collector's request for further inspection.
(2) If the employee claims that he or she has a medical condition that prevents opening his or her mouth for inspection, the collector follows the procedure described in § 40.193(a).
(3) If the collector observes materials brought to the collection site or the employee's conduct clearly indicates an attempt to adulterate, substitute, or alter the specimen, the collector must terminate the collection, note the circumstances in the Remarks section of the CCF, and report the circumstances to the DER, so that the employer can decide whether to deem the situation a refusal in accordance with § 40.191(a).
(b) If an item is present that might impede or interfere with the collection of an oral fluid specimen, the collector must request the employee remove the item.
(1) If the employee removes any item that could impede or interfere with the collection of an oral fluid specimen, the employee has abnormally colored saliva, or the employee claims to have “dry mouth,” then the collector must give the employee water, up to 8 ounces, to rinse their mouth. The employee may drink the water. The collector must then wait 10 minutes before beginning the specimen collection.
(2) If the employee refuses to remove the item or rinse, the collector must terminate the collection, note the circumstances in the Remarks section of the CCF, and report the information to the DER to test as described in § 40.191(a)(8) (failure to cooperate), so that the employer can decide whether to deem the situation a refusal.
(c) If there is nothing of concern in the oral cavity and no “dry mouth” condition, the collector starts a 10-minute wait period and proceeds with the steps below before beginning the specimen collection as described in § 40.73.
(d) During the 10-minute wait period:
(1) Review with the employee the procedures required for a successful oral fluid specimen collection as stated in the manufacturer's instructions for the specimen collection device.
(2) Complete all items under Step 1 of the CCF, and for clarification:
(i) In Step 1.D of the CCF, the collector must put a check mark for the “Specify DOT Agency” under whose authority the test will take place.
(ii) In Step 1.G of the CCF for the “Collection Site Address”, the collector must provide the address where the collection took place.
(3) The collector will provide, or the employee may select, a specimen collection device that is clean, unused, and wrapped/sealed in original packaging.
(i) The collector will check the expiration date on the device or the package containing the device and show it to the employee.
(ii) The collector must not use the device after its expiration date.
(iii) The collector must open the specimen collection device in view of the employee.
(4) The collector will complete Step 2 of the CCF.
(i) Check “Oral Fluid”,
(ii) For “Oral Fluid: Split Type” check “Subdivided”, and
(iii) Check “Each Device Within Expiration Date?” after ensuring the device is within its expiration date.
(5) The collector will enter the Split Specimen Device Expiration Date in Step 4 of the CCF. Since the collector will use one oral fluid device that will collect a single specimen, which is then subdivided in the presence of the donor, only one entry in Step 4 is to be made for the device expiration date.
(6) The collector must instruct the employee to use hand sanitizer or wash and dry his or her hands.
(e) To the greatest extent practicable, the collector must keep the employee's unwrapped collection device within view of both the collector and the employee, between the time the employee has provided a specimen and the specimen is sealed.
§ 40.73   How is an oral fluid specimen collected?
(a) The collector must be present and maintain visual contact with the employee during the procedures outlined in this section.
(1) As the oral fluid collector, you must not allow any person other than you, the employee, or a DOT agency representative to actually witness the testing process.
(2) [Reserved]
(b) The collector must note any unusual behavior or appearance of the employee on the CCF. If the collector detects any conduct that clearly indicates an attempt to tamper with a specimen ( e.g., an attempt to bring into the collection site an adulterant or oral fluid substitute), the collector must terminate the collection and report the information to the DER so that the employer can decide whether to deem the situation a refusal.
(c) The employee and collector must complete the specimen collection in accordance with the manufacturer's instructions for the collection device.
(1) Under the observation of the collector, the employee is responsible for positioning the specimen collection device for collection.
(2) The collector must ensure the collection is performed correctly ( i.e., using the oral fluid device in the manner described by its manufacturer), that the collection device is working properly, and that a sufficient specimen volume is collected. After the employee provides a sufficient specimen, check the “Volume Indicator(s) Observed” box in Step 2 of the Federal CCF to document that you observed the volume indicator(s) during the collection.
(3) If the employee states that he or she is unable to provide an oral fluid specimen or provides an insufficient specimen during the collection process, the collector must continue to make one attempt to collect, after an insufficient specimen, the collector follows the procedure in § 40.193.
(4) The collector must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering. If it is apparent from this inspection that the employee has tampered with the specimen, the collector must conduct a new collection.
(i) Document any unusual characteristics referenced above in the Remarks section of the CCF.
(ii) Proceed with obtaining the new oral fluid specimen from the donor. Note on the new CCF that this is another collection for the same testing event ( i.e., Document in the remarks section that this is Specimen 2 of 2 and include the Specimen ID number of the other specimen). Make the same notation on the CCF of the suspect specimen.
§ 40.74   How does the collector prepare the oral fluid specimens?
(a) The collector follows the manufacturer's instructions to package the split specimen collections.
(b) A volume of at least 1 mL of undiluted (neat) oral fluid is collected for the specimen designated as “Bottle A”, and a volume of at least 1 mL of undiluted (neat) oral fluid is collected for the specimen designated as “Bottle B”, or an otherwise sufficient amount of oral fluid is collected to permit an HHS-certified laboratory to analyze the specimen(s).
(c) In the presence of the employee, the collector places a tamper-evident seal from the CCF over the cap of each specimen container, taking care not to obstruct the expiration date on the collection containers. The collector must record the date of the collection on the tamper-evident seals, after they are affixed to the specimen containers.
(d) The collector instructs the employee to initial the tamper-evident seals on each specimen container. If the employee declines to do so, the collector must note this in the “Remarks” line of the CCF (Step 2) and complete the collection process.
§§ 40.75-40.78   [Reserved]
§ 40.79   How is the collection process completed?
(a) As the collector, when using the paper CCF, you must do the following things to complete the collection process. You must complete the steps called for in paragraphs (a)(1) through (7) of this section in the employee's presence.
(1) Direct the employee to read and sign the certification statement on Copy 2 of the CCF and provide all information required in Step 5. If the employee declines to sign the CCF or to provide any of the required information, you must note this in the “Remarks” line (Step 2) of the CCF and complete the collection. If the employee declines to fill out any information, you must, as a minimum, print the employee's name in the appropriate place.
(2) Complete the chain of custody on the CCF (Step 4) by printing your name (note: you may pre-print your name), recording the time and date of the collection, signing the statement, and entering the name of the delivery service transferring the specimen to the laboratory,
(3) Ensure that all copies of the CCF are legible and complete.
(4) Remove Copy 5 of the CCF and give it to the employee.
(5) Place the specimen bottles and Copy 1 of the CCF in the appropriate pouches of the plastic bag.
(6) Secure both pouches of the plastic bag.
(7) Advise the employee that he or she may leave the collection site.
(8) To prepare the sealed plastic bag containing the specimens and CCF for shipment you must:
(i) Place the sealed plastic bag in a shipping container ( e.g., standard courier box) designed to minimize the possibility of damage during shipment. (More than one sealed plastic bag can be placed into a single shipping container if you are doing multiple collections.)
(ii) Seal the container as appropriate.
(iii) If a laboratory courier hand-delivers the specimens from the collection site to the laboratory, prepare the sealed plastic bag for shipment as directed by the courier service.
(9) Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You must fax or otherwise transmit these copies to the MRO and DER within 24 hours or during the next business day. Keep Copy 3 for at least 30 days, unless otherwise specified by applicable DOT agency regulations.
(b) As a collector, when using other forms of the CCF as approved by the Office of Management and Budget, you must follow the procedures approved for that form.
(c) As a collector or collection site, you must ensure that each specimen you collect is shipped to a laboratory as quickly as possible, but in any case, within 24 hours or during the next business day.
§ 40.81   What laboratories may be used for DOT drug testing?
(a) As a drug testing laboratory located in the U.S., you are permitted to participate in DOT drug testing only if you are certified by HHS under the National Laboratory Certification Program (NLCP) for each specimen testing methodology performed under this part.
(b) As a drug testing laboratory located in Canada or Mexico which is not certified by HHS under the NLCP, you are permitted to participate in DOT drug testing only if:
(1) The DOT, based on a written recommendation from HHS, has approved your laboratory as meeting HHS laboratory certification standards or deemed your laboratory fully equivalent to a laboratory meeting HHS laboratory certification standards for all testing required under this part; or
(2) The DOT, based on a written recommendation from HHS, has recognized a Canadian or Mexican certifying organization as having equivalent laboratory certification standards and procedures to those of HHS, and the Canadian or Mexican certifying organization has certified your laboratory under those equivalent standards and procedures.
(c) As a laboratory participating in the DOT drug testing program, you must comply with the requirements of this part. You must also comply with all applicable requirements of HHS in testing DOT specimens, whether or not the HHS requirements are explicitly stated in this part.
(d) If DOT determines that you are in noncompliance with this part, you could be subject to PIE proceedings under Subpart R of this part. If the Department issues a PIE with respect to you, you are ineligible to participate in the DOT drug testing program even if you continue to meet the requirements of paragraph (a) or (b) of this section.
§ 40.82   What drugs do laboratories test for?
As a laboratory, you must test for the following five drugs or classes of drugs in a DOT drug test. You must not test “DOT specimens” for any other drugs.
(a) Marijuana metabolites.
(b) Cocaine metabolites.
(c) Amphetamines.
(d) Opioids.
(e) Phencyclidine (PCP).
§ 40.83   How do laboratories process incoming specimens?
As the laboratory, you must do the following when you receive a DOT specimen:
(a) You are authorized to receive only Copy 1 of the CCF. You are not authorized to receive other copies of the CCF or any copies of the alcohol testing form.
(b) You must comply with applicable provisions of the HHS Guidelines concerning accessioning and processing drug specimens.
(c) You must inspect each specimen and CCF for the following “fatal flaws”:
(1) There is no CCF;
(2) In cases where a specimen has been collected, there is no specimen submitted with the CCF;
(3) There is no printed collector's name and no collector's signature;
(4) Two separate collections are performed using one CCF;
(5) The specimen ID numbers on the specimen bottle and the CCF do not match;
(6) The specimen bottle seal is broken or shows evidence of tampering, unless a split specimen can be redesignated (see paragraph (h) of this section);
(7) There is an insufficient amount of specimen in the primary bottle for analysis, unless the specimens can be redesignated (see paragraph (h) of this section).
(8) For an oral fluid collection, the collector used an expired device at the time of collection.
(9) For an oral fluid collection, if the collector failed to enter the expiration date in Step 4 of the CCF and the laboratory is unable to determine the expiration date by inspecting Bottles A and B.
(d) When you find a specimen meeting the criteria of paragraph (c) of this section, you must document your findings and stop the testing process. Report the result in accordance with § 40.97(b)(3) .
(e) You must inspect each CCF for the presence of the collector's signature on the certification statement in Step 4 of the CCF. Upon finding that the signature is omitted, document the flaw and continue the testing process.
(1) In such a case, you must retain the specimen for a minimum of 5 business days from the date on which you initiated action to correct the flaw.
(2) You must then attempt to correct the flaw by following the procedures of § 40.205(b)(1).
(3) If the flaw is not corrected, report the result as rejected for testing in accordance with § 40.97(b)(3).
(f) If you determine that the urine specimen temperature was not checked and the “Remarks” line did not contain an entry regarding the temperature being outside of range, you must then attempt to correct the problem by following the procedures of § 40.208.
(1) In such a case, you must continue your efforts to correct the problem for five business days, before you report the result.
(2) When you have obtained the correction, or five business days have elapsed, report the result in accordance with § 40.97(b).
(g) If you determine that a CCF that fails to meet the requirements of § 40.40(a) (e.g., a non-Federal form or an expired Federal form was used for the collection), you must attempt to correct the use of the improper form by following the procedures of § 40.205(b)(2).
(1) In such a case, you must retain the specimen for a minimum of 5 business days from the date on which you initiated action to correct the problem.
(2) If the problem(s) is not corrected, you must reject the test and report the result in accordance with § 40.97(b)(3).
(h) If the CCF is marked indicating that a split specimen collection was collected and if the split specimen does not accompany the primary, has leaked, or is otherwise unavailable for testing, you must still test the primary specimen and follow appropriate procedures outlined in § 40.175(b) regarding the unavailability of the split specimen for testing.
(1) The primary specimen and the split specimen can be redesignated ( i.e., Bottle B is redesignated as Bottle A, and vice-versa) if:
(i) The primary specimen appears to have leaked out of its sealed bottle and the laboratory believes a sufficient amount of specimen exists in the split specimen to conduct all appropriate primary laboratory testing; or
(ii) The primary specimen is labeled as Bottle B, and the split specimen as Bottle A; or
(iii) The laboratory opens the split specimen instead of the primary specimen, the primary specimen remains sealed, and the laboratory believes a sufficient amount of specimen exists in the split specimen to conduct all appropriate primary laboratory testing; or
(iv) The primary specimen seal is broken but the split specimen remains sealed and the laboratory believes a sufficient amount of specimen exists in the split specimen to conduct all appropriate primary laboratory testing.
(2) In situations outlined in paragraph (h)(1) of this section, the laboratory shall mark through the “A” and write “B,” then initial and date the change. A corresponding change shall be made to the other bottle by marking through the “B” and writing “A,” and initialing and dating the change.
(i) A notation shall be made on Copy 1 of the CCF (Step 5a) and on any laboratory internal chain of custody documents, as appropriate, for any fatal or correctable flaw.
§ 40.84   How long does the laboratory retain specimens after testing?
(a) As a laboratory testing the primary specimen, you must retain a specimen that was reported with positive, adulterated, substituted, or invalid results for a minimum of one year.
(b) You must keep such a specimen in secure, long-term, frozen storage in accordance with HHS requirements.
(c) Within the one-year period, the MRO, the employee, the employer, or a DOT agency may request in writing that you retain a specimen for an additional period of time ( e.g., for the purpose of preserving evidence for litigation or a safety investigation). If you receive such a request, you must comply with it. If you do not receive such a request, you may discard the specimen at the end of the year.
(d) If you have not sent the split specimen to another laboratory for testing, you must retain the split specimen for an employee's test for the same period of time that you retain the primary specimen and under the same storage conditions.
(e) As the laboratory testing the split specimen, you must meet the requirements of paragraphs (a) through (d) of this section with respect to the split specimen.
§ 40.85   What are the cutoff concentrations for urine drug tests?
(a) As a laboratory, you must use the cutoff concentrations displayed in the following table for initial and confirmatory drug tests. All cutoff concentrations are expressed in nanograms per milliliter (ng/mL). The table follows:
1 For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.
2 An immunoassay must be calibrated with a target analyte.
3 Alternate technology (THCA and Benzoylecgonine): When using an alternate technology initial test for the specific target analytes of THCA and Benzoylecgonine, the laboratory must use the same cutoff for the initial and confirmatory tests (i.e., 15 ng/mL for THCA and 100ng/mL for Benzoylecgonine).
4 Methylenedioxymethamphetamine (MDMA).
5 Methylenedioxyamphetamine (MDA).
(b) On an initial drug test, you must report a result below the cutoff concentration as negative. If the result is at or above the cutoff concentration, you must conduct a confirmation test.
(c) On a confirmation drug test, you must report a result below the cutoff concentration as negative and a result at or above the cutoff concentration as confirmed positive.
(d) You must report quantitative values for morphine or codeine at 15,000 ng/mL or above.
§ 40.86   What is urine validity testing, and are laboratories required to conduct it?
(a) Specimen validity testing is the evaluation of the specimen to determine if it is consistent with normal human urine. The purpose of validity testing is to determine whether certain adulterants or foreign substances were added to the urine, if the urine was diluted, or if the specimen was substituted.
(b) As a laboratory, you must conduct validity testing.
§ 40.87   What validity tests must laboratories conduct on primary urine specimens?
As a laboratory, when you conduct validity testing under § 40.86, you must conduct it in accordance with the requirements of this section.
(a) You must determine the creatinine concentration on each primary specimen. You must also determine its specific gravity if you find the creatinine concentration to be less than 20 mg/dL.
(b) You must determine the pH of each primary specimen.
(c) You must perform one or more validity tests for oxidizing adulterants on each primary specimen.
(d) You must perform additional validity tests on the primary specimen when the following conditions are observed:
(1) Abnormal physical characteristics;
(2) Reactions or responses characteristic of an adulterant obtained during initial or confirmatory drug tests ( e.g. , non-recovery of internal standards, unusual response); or
(3) Possible unidentified interfering substance or adulterant.
(e) If you determine that the specimen is invalid and HHS guidelines direct you to contact the MRO, you must contact the MRO and together decide if testing the primary specimen by another HHS certified laboratory would be useful in being able to report a positive or adulterated test result.
§ 40.88   What criteria do laboratories use to establish that a urine specimen is dilute or substituted?
(a) As a laboratory, you must consider the primary specimen to be dilute when:
(1) The creatinine concentration is greater than or equal to 2 mg/dL but less than 20 mg/dL, and
(2) The specific gravity is greater than 1.0010 but less than 1.0030 on a single aliquot.
(b) As a laboratory, you must consider the primary specimen to be substituted when the creatinine concentration is less than 2 mg/dL and the specific gravity is less than or equal to 1.0010 or greater than or equal to 1.0200 on both the initial and confirmatory creatinine tests and on both the initial and confirmatory specific gravity tests on two separate aliquots.
§ 40.89   What are the adulterant cutoff concentrations for initial and confirmation urine tests?
(a) As a laboratory, you must use the cutoff concentrations for the initial and confirmation adulterant testing as required by the HHS Mandatory Guidelines and you must use two separate aliquots—one for the initial test and another for the confirmation test.
(b) As a laboratory, you must report results at or above the cutoffs (or for pH, at or above or below the values, as appropriate) as adulterated and provide the numerical value that supports the adulterated result.
§ 40.90   What criteria do laboratories use to establish that a urine specimen is invalid?
(a) As a laboratory, you must use the invalid test result criteria for the initial and confirmation testing as required by the HHS Mandatory Guidelines, and you must use two separate aliquots—one for the initial test and another for the confirmation test.
(b) As a laboratory, for a specimen having an invalid result for one of the reasons outlined in the HHS Mandatory Guidelines, you must contact the MRO to discuss whether sending the specimen to another HHS certified laboratory for testing would be useful in being able to report a positive or adulterated result.
(c) As a laboratory, you must report invalid results in accordance with the invalid test result criteria as required by the HHS Guidelines and provide the numerical value that supports the invalid result, where appropriate, such as pH.
(d) As a laboratory, you must report the reason a test result is invalid.
§ 40.91   What are the cutoff concentrations for oral fluid drug tests?
As a laboratory, you must use the cutoff concentrations displayed in the following table for initial and confirmatory drug tests for oral fluid specimens. All cutoff concentrations are expressed in nanograms per milliliter (ng/mL). The table follows:
Table 1 to § 40.91—Oral Fluid Testing Cutoff Concentrations
1 For grouped analytes ( i.e., two or more analytes that are in the same drug class and have the same initial test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present ( i.e., with concentrations equal to or greater than the laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.
2 An immunoassay must be calibrated with the target analyte.
3 Alternate technology (THC and 6-AM): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the target analyte ( i.e., 2 ng/mL for THC, 2 ng/mL for 6-AM).
4 Methylenedioxymethamphetamine (MDMA).
5 Methylenedioxyamphetamine (MDA).
§ 40.92   What is oral fluid validity testing, and are laboratories required to conduct it?
(a) Specimen validity testing is the evaluation of the specimen to determine if it is consistent with normal human oral fluid. The purpose of validity testing is to determine whether certain adulterants or foreign substances were added to the oral fluid, if the oral fluid was altered.
(b) If a specimen exhibits abnormal characteristics ( e.g., unusual odor or color), causes reactions or responses characteristic of an adulterant during initial or confirmatory drug tests ( e.g., non-recovery of internal standard, unusual response), or contains an unidentified substance that interferes with the confirmatory analysis, then you may conduct validity testing.
(c) If you determine that the specimen is invalid and HHS guidelines direct you to contact the MRO, you must contact the MRO and together decide if testing the primary specimen by another HHS-certified laboratory would be useful in being able to report a positive or adulterated test result.
§ 40.93   What validity tests must laboratories conduct on primary oral fluid specimens?
As a laboratory, if you conduct validity testing under § 40.92, you must conduct it in accordance with the requirements of this section.
(a) You may test for a biomarker such as albumin or immunoglobulin G (IgG) or a test for a specific adulterant.
(b) You must follow the applicable HHS requirements for any additional validity testing.
§ 40.97   What do laboratories report and how do they report it?
(a) As a laboratory, when reporting a result of any kind, you must report the specimen type.
(b) You must also report the results for each primary specimen, which will fall into one of the following three categories. As a laboratory, you must report the actual results (and not the categories):
(1) Category 1: Negative results. As a laboratory, when you find a specimen to be negative, you must report the test result as being one of the following, as applicable:
(i) Negative, or
(ii) For urine only, negative-dilute, with numerical values for creatinine and specific gravity.
(2) Category 2: Non-negative results. As a laboratory, when you find a specimen to be non-negative, you must report the test result as being one or more of the following, as applicable:
(i) Positive, with drug(s)/metabolite(s) noted, with numerical values for the drug(s) or drug metabolite(s).
(ii) Adulterated, with adulterant(s) noted, with confirmatory test values (when applicable), and with remarks(s);
(iii) For urine only, positive-dilute, with drug(s)/metabolite(s) noted, with numerical values for the drug(s) or drug metabolite(s) and with numerical values for creatinine and specific gravity;
(iv) For urine only, substituted, with confirmatory test values for creatinine and specific gravity; or
(v) For urine only, invalid result, with remark(s). Laboratories will report actual values for pH results.
(vi) For oral fluid only, invalid result, with remark(s). Laboratories must report numerical values of the specimen validity test results that support a specimen reported as invalid.
(3) Category 3: Rejected for testing. As a laboratory, when you reject a specimen for testing, you must report the result as being Rejected for Testing, with remark(s).
(c) As a laboratory, you must report laboratory results directly, and only, to the MRO at his or her place of business. You must not report results to or through the DER or a service agent ( e.g., a C/TPA).
(1) Negative results: You must fax, courier, mail, or electronically transmit a legible image or copy of the fully completed Copy 1 of the CCF which has been signed by the certifying scientist, or you may provide the laboratory results report electronically ( i.e., computer data file).
(i) If you elect to provide the laboratory results report, you must include the following elements, as a minimum, in the report format:
(A) Laboratory name and address;
(B) Employer's name (you may include I.D. or account number);
(C) Medical review officer's name;
(D) Specimen I.D. number;
(E) SSN or Employee ID from Step 1C of the CCF, if provided;
(F) Reason for test, if provided;
(G) Collector's name and telephone number;
(H) Date of the collection;
(I) For oral fluid only, collection device expiration date;
(J) Date received at the laboratory;
(K) Date certifying scientist released the results;
(L) Certifying scientist's name;
(M) Results ( e.g., positive, adulterated) as listed in paragraph (b) of this section; and
(N) Remarks section, with an explanation of any situation in which a correctable flaw has been corrected.
(ii) You may release the laboratory results report only after review and approval by the certifying scientist. It must reflect the same test result information as contained on the CCF signed by the certifying scientist. The information contained in the laboratory results report must not contain information that does not appear on the CCF.
(iii) The results report may be transmitted through any means that ensures accuracy and confidentiality. You, as the laboratory, together with the MRO, must ensure that the information is adequately protected from unauthorized access or release, both during transmission and in storage ( e.g., see § 40.351).
(2) Non-negative and Rejected for Testing results: You must fax, courier, mail, or electronically transmit a legible image or copy of the fully completed Copy 1 of the CCF that has been signed by the certifying scientist. In addition, you may provide the electronic laboratory results report following the format and procedures set forth in paragraphs (c)(1)(i) and (ii) of this section.
(d) In transmitting laboratory results to the MRO, you, as the laboratory, together with the MRO, must ensure that the information is adequately protected from unauthorized access or release, both during transmission and in storage. If the results are provided by fax or other electronic means, the electronic communication must be accessible only to authorized individuals.
(e) You must transmit test results to the MRO in a timely manner, preferably the same day that review by the certifying scientist is completed.
(f)(1) You must provide quantitative values for confirmed positive drug test results to the MRO.
(2) You must provide numerical values that support the adulterated (when applicable) or substituted result, without a request from the MRO.
(3) You must also provide the MRO numerical values for creatinine and specific gravity for the negative-dilute urine test result, without a request from the MRO.
(g) You must provide quantitative values for confirmed positive morphine and/or codeine urine results at or below 15,000 ng/mL, and for confirmed positive morphine or codeine oral fluid results at or below 150 ng/mL.
§ 40.101   What relationship may a laboratory have with an MRO?
(a) As a laboratory, you may not enter into any relationship with an MRO that creates a conflict of interest or the appearance of a conflict of interest with the MRO's responsibilities for the employer. You may not derive any financial benefit by having an employer use a specific MRO.
(b) The following are examples of relationships between laboratories and MROs that the Department regards as creating conflicts of interest, or the appearance of such conflicts. This following list of examples is not intended to be exclusive or exhaustive:
(1) The laboratory employs an MRO who reviews test results produced by the laboratory;
(2) The laboratory has a contract or retainer with the MRO for the review of test results produced by the laboratory;
(3) The laboratory designates which MRO the employer is to use, gives the employer a slate of MROs from which to choose, or recommends certain MROs;
(4) The laboratory gives the employer a discount or other incentive to use a particular MRO;
(5) The laboratory has its place of business co-located with that of an MRO or MRO staff who review test results produced by the laboratory; or
(6) The laboratory permits an MRO, or an MRO's organization, to have a financial interest in the laboratory.
§ 40.107   Who may inspect laboratories?
As a laboratory, you must permit an inspection, with or without prior notice, by ODAPC, a DOT agency, or a DOT-regulated employer that contracts with the laboratory for drug testing under the DOT drug testing program, or the designee of such an employer.
§ 40.109   What documentation must the laboratory keep, and for how long?
(a) As a laboratory, you must retain all records pertaining to each employee urine specimen for a minimum of two years.
(b) As a laboratory, you must also keep for two years employer-specific data required in § 40.111.
(c) Within the two-year period, the MRO, the employee, the employer, or a DOT agency may request in writing that you retain the records for an additional period of time ( e.g., for the purpose of preserving evidence for litigation or a safety investigation). If you receive such a request, you must comply with it. If you do not receive such a request, you may discard the records at the end of the two-year period.
§ 40.111   When and how must a laboratory disclose statistical summaries and other information it maintains?
(a) As a laboratory, you must transmit an aggregate statistical summary, by employer, of the data listed in appendix D of this part with respect to each specimen type for which you conduct tests to the employer on a semi-annual basis.
(1) The summary must not reveal the identity of any employee.
(2) In order to avoid sending data from which it is likely that information about an employee's test result can be readily inferred, you must not send a summary if the employer has fewer than five aggregate tests results.
(3) The summary must be sent by January 20 of each year for July 1 through December 31 of the prior year.
(4) The summary must also be sent by July 20 of each year for January 1 through June 30 of the current year.
(b) When the employer requests a summary in response to an inspection, audit, or review by a DOT agency, you must provide it unless the employer had fewer than five aggregate test results. In that case, you must send the employer a report indicating that not enough testing was conducted to warrant a summary. You may transmit the summary or report by hard copy, fax, or other electronic means.
(c) You must also release information to appropriate parties as provided in §§ 40.329 and 40.331.
(d) As a laboratory, you must transmit an aggregate statistical summary listed in appendix E of this part for each specimen type for which you conduct testing to DOT on a semi-annual basis. The summary must be sent by January 31 of each year for July 1 through December 31 of the prior year. It must be sent by July 31 of each year for January 1 through June 30 of the current year. If you withdraw or are removed from NLCP's laboratory certification during a reporting period, you must provide the aggregate statistical summary to the DOT-regulated employers and to ODAPC for the last reporting period in which you conducted DOT-regulated testing.
§ 40.121   Who is qualified to act as an MRO?
To be qualified to act as an MRO in the DOT drug testing program, you must meet each of the requirements of this section:
(a) Credentials. You must be a licensed physician (Doctor of Medicine or Osteopathy). If you are a licensed physician in any U.S., Canadian, or Mexican jurisdiction and meet the other requirements of this section, you are authorized to perform MRO services with respect to all covered employees, wherever they are located. For example, if you are licensed as an M.D. in one state or province in the U.S., Canada, or Mexico, you are not limited to performing MRO functions in that state or province, and you may perform MRO functions for employees in other states or provinces without becoming licensed to practice medicine in the other jurisdictions.
(b) Basic knowledge. You must be knowledgeable in the following areas:
(1) You must be knowledgeable about and have clinical experience in controlled substances abuse disorders, including detailed knowledge of alternative medical explanations for laboratory confirmed drug test results.
(2) You must be knowledgeable about issues relating to adulterated and substituted specimens as well as the possible medical causes of specimens having an invalid result.
(3) You must be knowledgeable about this part, the DOT MRO Guidelines, and the DOT agency regulations applicable to the employers for whom you evaluate drug test results, and you must keep current on any changes to these materials. You must subscribe to the ODAPC list-serve at https://www.transportation.gov/odapc/get-odapc-email-updates. DOT agency regulations, DOT MRO Guidelines, and other materials are available from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, 202-366-3784), or on the ODAPC Web site ( http://www.transportation.gov/odapc ).
(c) Qualification training. You must receive qualification training meeting the requirements of this paragraph (c).
(1) Qualification training must provide instruction on the following subjects:
(i) Collection procedures for specimens;
(ii) Chain of custody, reporting, and recordkeeping;
(iii) Interpretation of drug and validity tests results;
(iv) The role and responsibilities of the MRO in the DOT drug testing program;
(v) The interaction with other participants in the program ( e.g., DERs, SAPs); and
(vi) Provisions of this part and DOT agency rules applying to employers for whom you review test results, including changes and updates to this part and DOT agency rules, guidance, interpretations, and policies affecting the performance of MRO functions, as well as issues that MROs confront in carrying out their duties under this part and DOT agency rules.
(2) Following your completion of qualification training under paragraph (c)(1) of this section, you must satisfactorily complete an examination administered by a nationally-recognized MRO certification board or subspecialty board for medical practitioners in the field of medical review of DOT-mandated drug tests. The examination must comprehensively cover all the elements of qualification training listed in paragraph (c)(1) of this section.
(3) You must meet the requirements of paragraphs (a), (b), and (c) of this section before you begin to perform MRO functions.
(d) Requalification training. During each five-year period from the date on which you satisfactorily completed the examination under paragraph (c)(2) of this section, you must complete requalification training.
(1) This requalification training must meet the requirements of the qualification training under paragraph (c)(1) of this section.
(2) Following your completion of requalification training, you must satisfactorily complete an examination administered by a nationally-recognized MRO certification board or subspecialty board for medical practitioners in the field of medical review of DOT-mandated drug tests. The examination must comprehensively cover all the elements of qualification training listed in paragraph (c)(1) of this section.
(e) Documentation. You must maintain documentation showing that you currently meet all requirements of this section. You must provide this documentation on request to DOT agency representatives and to employers and C/TPAs who are using or negotiating to use your services.
§ 40.123   What are the MRO's responsibilities in the DOT drug testing program?
As an MRO, you have the following basic responsibilities:
(a) Acting as an independent and impartial “gatekeeper” and advocate for the accuracy and integrity of the drug testing process.
(b) Providing a quality assurance review of the drug testing process for the specimens under your purview. This includes, but is not limited to:
(1) Ensuring the review of the CCF on all specimen collections for the purposes of determining whether there is a problem that may cause a test to be cancelled (see §§ 40.199-40.203). As an MRO, you are not required to review laboratory internal chain of custody documentation. No one is permitted to cancel a test because you have not reviewed this documentation;
(2) Providing feedback to employers, collection sites and laboratories regarding performance issues where necessary; and
(3) Reporting to and consulting with the ODAPC or a relevant DOT agency when you wish DOT assistance in resolving any program issue. As an employer or service agent, you are prohibited from limiting or attempting to limit the MRO's access to DOT for this purpose and from retaliating in any way against an MRO for discussing drug testing issues with DOT.
(c) You must determine whether there is a legitimate medical explanation for confirmed positive, adulterated, substituted, and invalid results from the laboratory.
(d) While you provide medical review of employees' test results, this part does not deem that you have established a doctor-patient relationship with the employees whose tests you review.
(e) You must act to investigate and correct problems where possible and notify appropriate parties ( e.g., HHS, DOT, employers, service agents) where assistance is needed, ( e.g., cancelled or problematic tests, incorrect results).
(f) You must ensure the timely flow of test results and other information to employers.
(g) You must protect the confidentiality of the drug testing information.
(h) You must perform all your functions in compliance with this part and other DOT agency regulations.
§ 40.125   What relationship may an MRO have with a laboratory?
As an MRO, you may not enter into any relationship with an employer's laboratory that creates a conflict of interest or the appearance of a conflict of interest with your responsibilities to that employer. You may not derive any financial benefit by having an employer use a specific laboratory. For examples of relationships between laboratories and MROs that the Department views as creating a conflict of interest or the appearance of such a conflict, see § 40.101(b).
§ 40.127   What are the MRO's functions in reviewing negative test results?
As the MRO, you must do the following with respect to negative drug test results you receive from a laboratory, prior to verifying the result and releasing it to the DER:
(a) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to initiate corrective action or to cancel the test (see §§ 40.199 and 40.203).
(b) Review the negative laboratory test result and ensure that it is consistent with the information contained on the CCF.
(c) Before you report a negative test result, you must have in your possession the following documents:
(1) Copy 2 of the CCF, a legible copy of it, or any other CCF copy containing the employee's signature; and
(2) A legible copy (fax, photocopy, image) of Copy 1 of the CCF or the electronic laboratory results report that conveys the negative laboratory test result.
(d) If the copy of the documentation provided to you by the collector or laboratory appears unclear, you must request that the collector or laboratory send you a legible copy.
(e) On Copy 2 of the CCF, place a check mark in the “Negative” box (Step 6), provide your name, and sign, initial, or stamp and date the verification statement.
(f) Report the result in a confidential manner (see §§ 40.163-40.167).
(g) Staff under your direct, personal supervision may perform the administrative functions of this section for you, but only you can cancel a test. If you cancel a laboratory-confirmed negative result, check the “Test Cancelled” box (Step 6) on Copy 2 of the CCF, make appropriate annotation in the “Remarks” line, provide your name, and sign, initial or stamp and date the verification statement.
(1) On specimen results that are reviewed by your staff, you are responsible for assuring the quality of their work.
(2) You are required to personally review at least 5 percent of all CCFs reviewed by your staff on a quarterly basis, including all results that required a corrective action. However, you need not review more than 500 negative results of all specimen types combined in any quarter.
(3) Your review must, as a minimum, include the CCF, negative laboratory test result, any accompanying corrective documents, and the report sent to the employer. You must correct any errors that you discover. You must take action as necessary to ensure compliance by your staff with this part and document your corrective action. You must attest to the quality assurance review by initialing the CCFs that you review.
(4) You must make these CCFs easily identifiable and retrievable by you for review by DOT agencies.
§ 40.129   What are the MRO's functions in reviewing laboratory confirmed non-negative drug test results?
(a) As the MRO, you must do the following with respect to confirmed positive, adulterated, substituted, or invalid results you receive from a laboratory, before you verify the result and release it to the DER:
(1) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to cancel the test (see §§ 40.199 and 40.203). Staff under your direct, personal supervision may conduct this administrative review for you, but only you may verify or cancel a test.
(2) Review Copy 1 of the CCF and ensure that it is consistent with the information contained on Copy 2, that the test result is legible, and that the certifying scientist signed the form. You are not required to review any other documentation generated by the laboratory during their analysis or handling of the specimen ( e.g., the laboratory internal chain of custody).
(3) If the copy of the documentation provided to you by the collector or laboratory appears unclear, you must request that the collector or laboratory send you a legible copy.
(4) Except in the circumstances spelled out in § 40.133 , conduct a verification interview. This interview must include direct contact in person or by telephone between you and the employee. You may initiate the verification process based on the laboratory results report.
(5) Verify the test result, consistent with the requirements of §§ 40.135 through 40.145, 40.159, and 40.160, as:
(i) Negative; or
(ii) Cancelled; or
(iii) Positive, and/or refusal to test because of adulteration or substitution.
(b) Before you report a verified negative, positive, refusal to test because of adulteration or substitution, you must have in your possession the following documents:
(1) Copy 2 of the CCF, a legible copy of it, or any other CCF copy containing the employee's signature; and
(2) A legible copy (fax, photocopy, image) of Copy 1 of the CCF, containing the certifying scientist's signature.
(c) With respect to verified positive test results, place a checkmark in the “Positive” box in Step 6 on Copy 2 of the CCF, indicate the drug(s)/metabolite(s) verified positive, and sign and date the verification statement.
(d) If you cancel a laboratory confirmed positive, adulterated, substituted, or invalid result, check the “test cancelled” box (Step 6) on Copy 2 of the CCF, make appropriate annotation in the “Remarks” line, sign, provide your name, and date the verification statement.
(e) Report the result in a confidential manner (see §§ 40.163-40.167).
(f) With respect to adulteration or substitution test results, check the “refusal to test because:” box (Step 6) on Copy 2 of the CCF, check the “Adulterated” or “Substituted” box, as appropriate, make appropriate annotation in the “Remarks” line, sign and date the verification statement.
(g) As the MRO, your actions concerning reporting confirmed positive, adulterated, or substituted results to the employer before you have completed the verification process are also governed by the stand-down provisions of § 40.21 .
(1) If an employer has a stand-down policy that meets the requirements of § 40.21 , you may report to the DER that you have received an employee's laboratory confirmed positive, adulterated, or substituted test result, consistent with the terms of the waiver the employer received. You must not provide any further details about the test result ( e.g., the name of the drug involved).
(2) If the employer does not have a stand-down policy that meets the requirements of § 40.21, you must not inform the employer that you have received an employee's laboratory confirmed positive, adulterated, or substituted test result until you verify the test result. For example, as an MRO employed directly by a company, you must not tell anyone on the company's staff or management that you have received an employee's laboratory confirmed test result.
§ 40.131   How does the MRO or DER notify an employee of the verification process after receiving laboratory confirmed non-negative drug test results?
(a) When, as the MRO, you receive a confirmed positive, adulterated, substituted, or invalid test result from the laboratory, you must contact the employee directly ( i.e., actually talk to the employee), on a confidential basis, to determine whether the employee wants to discuss the test result. In making this contact, you must explain to the employee that, if he or she declines to discuss the result, you will verify the test as positive or as a refusal to test because of adulteration or substitution, as applicable.
(b) As the MRO, staff under your personal supervision may conduct this initial contact for you.
(1) This staff contact must be limited to scheduling the discussion between you and the employee and explaining the consequences of the employee's declining to speak with you ( i.e., that the MRO will verify the test without input from the employee). If the employee declines to speak with you, the staff person must document the employee's decision, including the date and time.
(2) A staff person must not gather any medical information or information concerning possible explanations for the test result.
(3) A staff person may advise an employee to have medical information ( e.g., prescriptions, information forming the basis of a legitimate medical explanation for a confirmed positive test result) ready to present at the interview with the MRO.
(4) Since you are required to speak personally with the employee, face-to-face or on the phone, your staff must not inquire if the employee wishes to speak with you.
(c) As the MRO, you or your staff must make reasonable efforts to reach the employee at the day and evening telephone numbers listed on the CCF. Reasonable efforts include, as a minimum, three attempts, spaced reasonably over a 24-hour period, to reach the employee at the day and evening telephone numbers listed on the CCF. If you or your staff cannot reach the employee directly after making these efforts, you or your staff must take the following steps:
(1) Document the efforts you made to contact the employee, including dates and times. If both phone numbers are incorrect ( e.g., disconnected, wrong number), you may take the actions listed in paragraph (c)(2) of this section without waiting the full 24-hour period.
(2) Contact the DER, instructing the DER to contact the employee.
(i) You must simply direct the DER to inform the employee to contact you.
(ii) You must not inform the DER that the employee has a confirmed positive, adulterated, substituted, or invalid test result.
(iii) You must document the dates and times of your attempts to contact the DER, and you must document the name of the DER you contacted and the date and time of the contact.
(d) As the DER, you must attempt to contact the employee immediately, using procedures that protect, as much as possible, the confidentiality of the MRO's request that the employee contact the MRO. If you successfully contact the employee (i.e., actually talk to the employee), you must document the date and time of the contact, and inform the MRO. You must inform the employee that he or she should contact the MRO immediately. You must also inform the employee of the consequences of failing to contact the MRO within the next 72 hours (see § 40.133(a)(2)).
(1) As the DER, you must not inform anyone else working for the employer that you are seeking to contact the employee on behalf of the MRO.
(2) If, as the DER, you have made all reasonable efforts to contact the employee but failed to do so, you may place the employee on temporary medically unqualified status or medical leave. Reasonable efforts include, as a minimum, three attempts, spaced reasonably over a 24-hour period, to reach the employee at the day and evening telephone numbers listed on the CCF.
(i) As the DER, you must document the dates and times of these efforts.
(ii) If, as the DER, you are unable to contact the employee within this 24-hour period, you must leave a message for the employee by any practicable means ( e.g., voice mail, e-mail, letter) to contact the MRO and inform the MRO of the date and time of this attempted contact.
§ 40.133   Without interviewing the employee, under what circumstances may the MRO verify a test result as positive, or as a refusal to test because of adulteration or substitution, or as cancelled because the test was invalid?
(a) As the MRO, you normally may verify a confirmed positive test (for any drug or drug metabolite, including opiates), or as a refusal to test because of adulteration or substitution, only after interviewing the employee as provided in §§ 40.135-40.145 . However, there are three circumstances in which you may verify such a result without an interview:
(1) You may verify a test result as a positive or refusal to test, as applicable, if the employee expressly declines the opportunity to discuss the test with you. You must maintain complete documentation of this occurrence, including notation of informing, or attempting to inform, the employee of the consequences of not exercising the option to speak with the you.
(2) You may verify a test result as a positive or refusal to test, as applicable, if the DER has successfully made and documented a contact with the employee and instructed the employee to contact you and more than 72 hours have passed since the time the DER contacted the employee.
(3) You may verify a test result as a positive or refusal to test, as applicable, if neither you nor the DER, after making and documenting all reasonable efforts, has been able to contact the employee within ten days of the date on which the MRO receives the confirmed test result from the laboratory.
(b) As the MRO, you may verify an invalid test result as cancelled (with instructions to recollect immediately under direct observation) without interviewing the employee, as provided at § 40.159:
(1) If the employee expressly declines the opportunity to discuss the test with you;
(2) If the DER has successfully made and documented a contact with the employee and instructed the employee to contact you and more than 72 hours have passed since the time the DER contacted the employee; or
(3) If neither you nor the DER, after making and documenting all reasonable efforts, has been able to contact the employee within ten days of the date on which you received the confirmed invalid test result from the laboratory.
(c) As the MRO, after you verify a test result as a positive or as a refusal to test under this section, you must document the date and time and reason, following the instructions in § 40.163. For a cancelled test due to an invalid result under this section, you must follow the instructions in § 40.159(a)(5).
(d) As the MRO, after you have verified a test result under this section and reported the result to the DER, you must allow the employee to present information to you within 60 days of the verification to document that serious illness, injury, or other circumstances unavoidably precluded contact with the MRO and/or DER in the times provided. On the basis of such information, you may reopen the verification, allowing the employee to present information concerning whether there is a legitimate medical explanation of the confirmed test result.
§ 40.135   What does the MRO tell the employee at the beginning of the verification interview?
(a) As the MRO, you must tell the employee that the laboratory has determined that the employee's test result was positive, adulterated, substituted, or invalid, as applicable. You must also tell the employee of the drugs for which his or her specimen tested positive, or the basis for the finding of adulteration or substitution.
(b) You must explain the verification interview process to the employee and inform the employee that your decision will be based on information the employee provides in the interview.
(c) You must explain that, if further medical evaluation is needed for the verification process, the employee must comply with your request for this evaluation and that failure to do so is equivalent of expressly declining to discuss the test result.
(d) As the MRO, you must warn an employee who has a confirmed positive, adulterated, substituted or invalid result that you are required to provide to third parties drug test result information and medical information affecting the performance of safety-sensitive duties that the employee gives you in the verification process without the employee's consent (see § 40.327).
(1) You must give this warning to the employee before obtaining any medical information as part of the verification process.
(2) For purposes of this paragraph (d), medical information includes information on medications or other substances affecting the performance of safety-sensitive duties that the employee reports using or medical conditions the employee reports having.
(3) For purposes of this paragraph (d), the persons to whom this information may be provided include the employer, a SAP evaluating the employee as part of the return to duty process (see § 40.293(g)), DOT, another Federal safety agency ( e.g., the NTSB), or any state safety agency as required by state law.
(e) You must also advise the employee that, before informing any third party about any medication the employee is using pursuant to a legally valid prescription consistent with the Controlled Substances Act, you will allow 5 business days from the date you report the verified negative result for the employee to have the prescribing physician contact you to determine if the medication can be changed to one that does not make the employee medically unqualified or does not pose a significant safety risk. If, in your reasonable medical judgment, a medical qualification issue or a significant safety risk remains after you communicate with the employee's prescribing physician or after 5 business days, whichever is shorter, you must follow § 40.327. If, as the MRO, you receive information that eliminates the medical qualification issue or significant safety risk, you must transmit this information to any third party to whom you previously provided information under § 40.327.
§ 40.137   On what basis does the MRO verify test results involving marijuana, cocaine, amphetamines, semi-synthetic opioids, or PCP?
(a) As the MRO, you must verify a confirmed positive test result for marijuana, cocaine, amphetamines, semi-synthetic opioids ( i.e., hydrocodone, hydromorphone, oxycodone, and oxymorphone), and/or PCP unless the employee presents a legitimate medical explanation for the presence of the drug(s)/metabolite(s) in his or her system. In determining whether an employee's legally valid prescription consistent with the Controlled Substances Act for a substance in these categories constitutes a legitimate medical explanation, you must not question whether the prescribing physician should have prescribed the substance.
(b) You must offer the employee an opportunity to present a legitimate medical explanation in all cases.
(c) The employee has the burden of proof that a legitimate medical explanation exists. The employee must present information meeting this burden at the time of the verification interview. As the MRO, you have discretion to extend the time available to the employee for this purpose for up to five days before verifying the test result, if you determine that there is a reasonable basis to believe that the employee will be able to produce relevant evidence concerning a legitimate medical explanation within that time.
(d) If you determine that there is a legitimate medical explanation, you must verify the test result as negative. Otherwise, you must verify the test result as positive.
(e) In determining whether a legitimate medical explanation exists, you may consider the employee's use of a medication from a foreign country. You must exercise your professional judgment consistently with the following principles:
(1) There can be a legitimate medical explanation only with respect to a substance that is obtained legally in a foreign country.
(2) There can be a legitimate medical explanation only with respect to a substance that has a legitimate medical use. Use of a drug of abuse ( e.g., heroin, PCP, marijuana) or any other substance (see § 40.151(f) and (g)) that cannot be viewed as having a legitimate medical use can never be the basis for a legitimate medical explanation, even if the substance is obtained legally in a foreign country.
(3) Use of the substance can form the basis of a legitimate medical explanation only if it is used consistently with its proper and intended medical purpose.
(4) Even if you find that there is a legitimate medical explanation under this paragraph (e) and verify a test negative, you may have a responsibility to raise fitness-for-duty considerations with the employer (see § 40.327).
§ 40.139   On what basis does the MRO verify test results involving 6-acetylmorphine, codeine, and morphine?
As the MRO, you must proceed as follows when you receive a laboratory confirmed positive opiate result:
(a) If the laboratory confirms the presence of 6-acetylmorphine (6-AM) in the specimen, you must verify the test result positive.
(b) In the absence of 6-AM, if the laboratory confirms the presence of either morphine or codeine equal to or above 15,000 ng/mL (in urine) or equal to or above 150 ng/mL (in oral fluid), you must verify the test result as positive, unless the employee presents a legitimate medical explanation for the presence of the drug or drug metabolite in his or her system, as in the case of other drugs (see § 40.137). Consumption of food products ( e.g., poppy seeds) must not be considered a legitimate medical explanation for the employee having morphine or codeine at these concentrations.
(c) For all other codeine and morphine positive results, you must verify a confirmed positive test result only if you determine that there is clinical evidence, in addition to the test, of unauthorized use of any opium, opiate, or opium derivative ( i.e., morphine, codeine, or heroin).
(1) As an MRO, it is your responsibility to use your best professional and ethical judgement and discretion to determine whether there is clinical evidence of unauthorized use of opiates. Examples of information that you may consider in making this judgement include, but are not limited to, the following:
(i) Recent needle tracks;
(ii) Behavioral and psychological signs of acute opiate intoxication or withdrawal;
(iii) Clinical history of unauthorized use recent enough to have produced the laboratory test result;
(iv) Use of a medication from a foreign country. See § 40.137(e) for guidance on how to make this determination.
(2) In order to establish the clinical evidence referenced in paragraphs (c)(1)(i) and (ii) of this section, personal observation of the employee is essential.
(i) Therefore, you, as the MRO, must conduct, or cause another physician to conduct, a face-to-face examination of the employee.
(ii) No face-to-face examination is needed in establishing the clinical evidence referenced in paragraph (c)(1)(iii) or (iv) of this section.
(3) To be the basis of a verified positive result for codeine or morphine, the clinical evidence you find must concern a drug that the laboratory found in the specimen. (For example, if the test confirmed the presence of codeine, and the employee admits to unauthorized use of hydrocodone, you must not verify the test positive for codeine. The admission must be for the substance that was found through the actual drug test.)
(4) As the MRO, you have the burden of establishing that there is clinical evidence of unauthorized use of opiates referenced in this paragraph (c). If you cannot make this determination (e.g., there is not sufficient clinical evidence or history), you must verify the test as negative. The employee does not need to show you that a legitimate medical explanation exists if no clinical evidence is established.
§ 40.141   How does the MRO obtain information for the verification decision?
As the MRO, you must do the following as you make the determinations needed for a verification decision:
(a) You must conduct a medical interview. You must review the employee's medical history and any other relevant biomedical factors presented to you by the employee. You may direct the employee to undergo further medical evaluation by you or another physician.
(b) If the employee asserts that the presence of a drug or drug metabolite in his or her specimen results from taking prescription medication ( i.e., a legally valid prescription consistent with the Controlled Substances Act), you must review and take all reasonable and necessary steps to verify the authenticity of all medical records the employee provides.
(1) You may contact the employee's physician or other relevant medical personnel for further information.
(i) If you decide to contact the employee's pharmacy to authenticate whether the prescription offered by the employee was filled by the pharmacy, you or staff under your operational control can contact the pharmacy.
(ii) If you utilize staff to perform the inquiry in paragraph (b)(1)(i) of this section, you must ensure operational control over the hiring, firing, evaluation of the staff and you must oversee the performance of the function of contacting a pharmacy to authenticate specific prescription(s) ( e.g., outline or script what the staff will ask the pharmacy; occasionally monitor calls to assure quality control; or other methods to ensure the staff are properly conducting the calls with the pharmacies).
(2) You may request an HHS-certified laboratory with validated protocols ( see § 40.81(c)) to conduct testing for D,L stereoisomers of amphetamine and methamphetamine or testing for tetrahydrocannabivarin (THC-V) when verifying lab results, as you determine necessary.
§ 40.143   [Reserved]
§ 40.145   On what basis does the MRO verify test results involving adulteration or substitution?
(a) As an MRO, when you receive a laboratory report that a specimen is adulterated or substituted, you must treat that report in the same way you treat the laboratory's report of a confirmed positive for a drug or drug metabolite.
(b) You must follow the same procedures used for verification of a confirmed positive test for a drug or drug metabolite (see §§ 40.129-40.135, 40.141, 40.151), except as otherwise provided in this section.
(c) In the verification interview, you must explain the laboratory findings to the employee and address technical questions or issues the employee may raise.
(d) You must offer the employee the opportunity to present a legitimate medical explanation for the laboratory findings with respect to presence of the adulterant in, or the creatinine and specific gravity findings for, the specimen.
(e) The employee has the burden of proof that there is a legitimate medical explanation.
(1) To meet this burden in the case of an adulterated specimen, the employee must demonstrate that the adulterant found by the laboratory entered the specimen through physiological means.
(2) To meet this burden in the case of a substituted specimen, the employee must demonstrate that he or she did produce or could have produced urine through physiological means, meeting the creatinine concentration criterion of less than 2 mg/dL and the specific gravity criteria of less than or equal to 1.0010 or greater than or equal to 1.0200 (see § 40.88(b)).
(3) The employee must present information meeting this burden at the time of the verification interview. As the MRO, you have discretion to extend the time available to the employee for this purpose for up to five days before verifying the specimen, if you determine that there is a reasonable basis to believe that the employee will be able to produce relevant evidence supporting a legitimate medical explanation within that time.
(f) As the MRO or the employer, you are not responsible for arranging, conducting, or paying for any studies, examinations or analyses to determine whether a legitimate medical explanation exists.
(g) As the MRO, you must exercise your best professional judgment in deciding whether the employee has established a legitimate medical explanation.
(1) If you determine that the employee's explanation does not present a reasonable basis for concluding that there may be a legitimate medical explanation, you must report the test to the DER as a verified refusal to test because of adulteration or substitution, as applicable.
(2) If you believe that the employee's explanation may present a reasonable basis for concluding that there is a legitimate medical explanation, you must direct the employee to obtain, within the five-day period set forth in paragraph (e)(3) of this section, a further medical evaluation. This evaluation must be performed by a licensed physician (the “referral physician”), acceptable to you, with expertise in the medical issues raised by the employee's explanation. (The MRO may perform this evaluation if the MRO has appropriate expertise.)
(i) As the MRO or employer, you are not responsible for finding or paying a referral physician. However, on request of the employee, you must provide reasonable assistance to the employee's efforts to find such a physician. The final choice of the referral physician is the employee's, as long as the physician is acceptable to you.
(ii) As the MRO, you must consult with the referral physician, providing guidance to him or her concerning his or her responsibilities under this section. As part of this consultation, you must provide the following information to the referral physician:
(A) That the employee was required to take a DOT drug test, but the laboratory reported that the specimen was adulterated or substituted, which is treated as a refusal to test;
(B) The consequences of the appropriate DOT agency regulation for refusing to take the required drug test;
(C) That the referral physician must agree to follow the requirements of paragraphs (g)(3) through (g)(4) of this section; and
(D) That the referral physician must provide you with a signed statement of his or her recommendations.
(3) As the referral physician, you must evaluate the employee and consider any evidence the employee presents concerning the employee's medical explanation. You may conduct additional tests to determine whether there is a legitimate medical explanation. Any additional drug tests must be performed in an HHS-certified laboratory.
(4) As the referral physician, you must then make a written recommendation to the MRO about whether the MRO should determine that there is a legitimate medical explanation. As the MRO, you must seriously consider and assess the referral physician's recommendation in deciding whether there is a legitimate medical explanation.
(5) As the MRO, if you determine that there is a legitimate medical explanation, you must cancel the test and inform ODAPC in writing of the determination and the basis for it ( e.g., referral physician's findings, evidence produced by the employee).
(6) As the MRO, if you determine that there is not a legitimate medical explanation, you must report the test to the DER as a verified refusal to test because of adulteration or substitution.
(h) The following are examples of types of evidence an employee could present to support an assertion of a legitimate medical explanation for a substituted urine result.
(1) Medically valid evidence demonstrating that the employee is capable of physiologically producing urine meeting the creatinine and specific gravity criteria of § 40.88(b).
(i) To be regarded as medically valid, the evidence must have been gathered using appropriate methodology and controls to ensure its accuracy and reliability.
(ii) Assertion by the employee that his or her personal characteristics ( e.g., with respect to race, gender, weight, diet, working conditions) are responsible for the substituted result does not, in itself, constitute a legitimate medical explanation. To make a case that there is a legitimate medical explanation, the employee must present evidence showing that the cited personal characteristics actually result in the physiological production of urine meeting the creatinine and specific gravity criteria of § 40.88(b).
(2) Information from a medical evaluation under paragraph (g) of this section that the individual has a medical condition that has been demonstrated to cause the employee to physiologically produce urine meeting the creatinine and specific gravity criteria of § 40.88(b).
(i) A finding or diagnosis by the physician that an employee has a medical condition, in itself, does not constitute a legitimate medical explanation.
(ii) To establish there is a legitimate medical explanation, the employee must demonstrate that the cited medical condition actually results in the physiological production of urine meeting the creatinine and specific gravity criteria of § 40.88(b).
§ 40.147   [Reserved]
§ 40.149   May the MRO change a verified drug test result?
(a) As the MRO, you may change a verified test result only in the following situations:
(1) When you have reopened a verification that was done without an interview with an employee (see § 40.133(d)).
(2) If you receive information, not available to you at the time of the original verification, demonstrating that the laboratory made an error in identifying ( e.g., a paperwork mistake) or testing ( e.g., a false positive or negative) the employee's primary or split specimen. For example, suppose the laboratory originally reported a positive test result for Employee X and a negative result for Employee Y. You verified the test results as reported to you. Then the laboratory notifies you that it mixed up the two test results, and X was really negative and Y was really positive. You would change X's test result from positive to negative and contact Y to conduct a verification interview.
(3) If, within 60 days of the original verification decision—
(i) You receive information that could not reasonably have been provided to you at the time of the decision demonstrating that there is a legitimate medical explanation for the presence of drug(s)/metabolite(s) in the employee's specimen; or
(ii) You receive credible new or additional evidence that a legitimate medical explanation for an adulterated or substituted result exists.
(4) If you receive the information in paragraph (a)(3) of this section after the 60-day period, you must consult with ODAPC prior to changing the result.
(5) When you have made an administrative error and reported an incorrect result.
(b) If you change the result, you must immediately notify the DER in writing, as provided in §§ 40.163-40.165.
(c) You are the only person permitted to change a verified test result, such as a verified positive test result or a determination that an individual has refused to test because of adulteration or substitution. This is because, as the MRO, you have the sole authority under this part to make medical determinations leading to a verified test (e.g., a determination that there was or was not a legitimate medical explanation for a laboratory test result). For example, an arbitrator is not permitted to overturn the medical judgment of the MRO that the employee failed to present a legitimate medical explanation for a positive, adulterated, or substituted test result of his or her specimen.
§ 40.151   What are MROs prohibited from doing as part of the verification process?
As an MRO, you are prohibited from doing the following as part of the verification process:
(a) You must not consider any evidence (verbal or written information) from any drug tests that are not collected or tested in accordance with this part. For example, if an employee tells you he went to his own physician, provided a urine specimen, sent it to a laboratory, and received a negative test result, you are required to ignore this test result.
(b) It is not your function to make decisions about factual disputes between the employee and the collector concerning matters occurring at the collection site that are not reflected on the CCF ( e.g., concerning allegations that the collector left the area or left open collection containers where other people could access them.)
(c) It is not your function to determine whether the employer should have directed that a test occur. For example, if an employee tells you that the employer misidentified her as the subject of a random test, or directed her to take a reasonable suspicion or post-accident test without proper grounds under a DOT agency drug or alcohol regulation, you must inform the employee that you cannot play a role in deciding these issues.
(d) It is not your function to consider explanations of confirmed positive, adulterated, or substituted test results that would not, even if true, constitute a legitimate medical explanation. For example, an employee may tell you that someone slipped amphetamines into her drink at a party, that she unknowingly ingested a marijuana brownie, or that she traveled in a closed car with several people smoking crack. MROs are unlikely to be able to verify the facts of such passive or unknowing ingestion stories. Even if true, such stories do not present a legitimate medical explanation. Consequently, you must not declare a test as negative based on an explanation of this kind.
(e) You must not verify a test negative based on information that a physician recommended that the employee use a drug listed in Schedule I of the Controlled Substances Act. ( e.g., under a state law that purports to authorize such recommendations, such as the “medical marijuana” laws that some states have adopted).
(f) You must not accept an assertion of consumption or other use of a hemp or other non-prescription marijuana-related product as a basis for verifying a marijuana test negative. You also must not accept such an explanation related to consumption of coca teas as a basis for verifying a cocaine test result as negative. Consuming or using such a product is not a legitimate medical explanation.
(g) You must not accept an assertion that there is a legitimate medical explanation for the presence of PCP, 6-AM, MDMA, or MDA in a specimen.
(h) You must not accept, as a legitimate medical explanation for an adulterated specimen, an assertion that soap, bleach, or glutaraldehyde entered a specimen through physiological means. There are no physiological means through which these substances can enter a specimen.
(i) You must not accept, as a legitimate medical explanation for a substituted specimen, an assertion that an employee can produce a urine specimen for which the creatinine level is below the laboratory's limit of detection. There are no physiological means through which a person can produce a urine specimen having this characteristic.
§ 40.153   How does the MRO notify employees of their right to a test of the split specimen?
(a) As the MRO, when you have verified a drug test as positive for a drug or drug metabolite, or as a refusal to test because of adulteration or substitution, you must notify the employee of his or her right to have the split specimen tested. You must also notify the employee of the procedures for requesting a test of the split specimen.
(b) You must inform the employee that he or she has 72 hours from the time you provide this notification to him or her to request a test of the split specimen.
(c) You must tell the employee how to contact you to make this request. You must provide telephone numbers or other information that will allow the employee to make this request. As the MRO, you must have the ability to receive the employee's calls at all times during the 72 hour period ( e.g., by use of an answering machine with a “time stamp” feature when there is no one in your office to answer the phone).
(d) You must tell the employee that if he or she makes this request within 72 hours, the employer must ensure that the test takes place, and that the employee is not required to pay for the test from his or her own funds before the test takes place. You must also tell the employee that the employer may seek reimbursement for the cost of the test (see § 40.173).
(e) You must tell the employee that additional tests of the specimen e.g., DNA tests) are not authorized.
§ 40.155   What does the MRO do when a negative or positive test result is also dilute?
(a) When the laboratory reports that a specimen is dilute, you must, as the MRO, report to the DER that the specimen, in addition to being negative or positive, is dilute.
(b) You must check the “dilute” box (Step 6) on Copy 2 of the CCF.
(c) When you report a dilute specimen to the DER, you must explain to the DER the employer's obligations and choices under § 40.197, to include the requirement for an immediate recollection under direct observation if the creatinine concentration of a negative-dilute specimen was greater than or equal to 2mg/dL but less than or equal to 5mg/dL.
(d) If the employee's recollection under direct observation, in paragraph (c) of this section, results in another negative-dilute, as the MRO, you must:
(1) Review the CCF to ensure that there is documentation that the recollection was directly observed.
(2) If the CCF documentation shows that the recollection was directly observed as required, report this result to the DER as a negative-dilute result.
(3) If CCF documentation indicates that the recollection was not directly observed as required, do not report a result but again explain to the DER that there must be an immediate recollection under direct observation.
§ 40.157   [Reserved]
§ 40.159   What does the MRO do when a drug test result is invalid?
(a) As the MRO, when the laboratory reports that the test result is an invalid result, you must do the following:
(1) Discuss the laboratory results with a certifying scientist to determine if the primary specimen should be tested at another HHS-certified laboratory. If the laboratory did not contact you as required by §§ 40.87(e) and 40.90(b), you must contact the laboratory.
(2) If you and the laboratory have determined that no further testing is necessary, contact the employee and inform the employee that the specimen was invalid. In contacting the employee, use the procedures set forth in § 40.131.
(3) After explaining the limits of disclosure (see §§ 40.135(d) and 40.327), you must determine if the employee has a medical explanation for the invalid result. You must inquire about the medications the employee may have taken.
(4) If the employee gives an explanation that is acceptable, you must:
(i) Place a check mark in the “Test Cancelled” box (Step 6) on Copy 2 of the CCF and enter “Invalid Result” and “direct observation collection not required” on the “Remarks” line.
(ii) Report to the DER that the test is cancelled, the reason for cancellation, and that no further action is required unless a negative test result is required ( i.e., pre-employment, return-to-duty, or follow-up tests).
(iii) If a negative test result is required and the medical explanation concerns a situation in which the employee has a permanent or long-term medical condition that precludes him or her from providing a valid specimen, as the MRO, you must follow the procedures outlined at § 40.160 for determining if there is clinical evidence that the individual is an illicit drug user.
(5) If the employee is unable to provide an explanation and/or a valid prescription for a medication that interfered with the immunoassay test but denies having adulterated the specimen, you must:
(i) Place a check mark in the “Test Cancelled” box (Step 6) on Copy 2 of the CCF and enter “Invalid Result” and “direct observation collection required” on the “Remarks” line.
(ii) Report to the DER that the test is cancelled, the reason for cancellation, and that a second collection must take place immediately under direct observation. Recommend to the employer that an alternate specimen should be collected if practicable ( e.g., oral fluid, if the specimen was urine).
(iii) Instruct the employer to ensure that the employee has the minimum possible advance notice that he or she must go to the collection site.
(6) When the test result is invalid because pH is greater than or equal to 9.0 but less than or equal to 9.5 and the employee has no other medical explanation for the pH, you should consider whether there is evidence of elapsed time and increased temperature that could account for the pH value.
(i) You are authorized to consider the temperature conditions that were likely to have existed between the time of collection and transportation of the specimen to the laboratory, and the length of time between the specimen collection and arrival at the laboratory.
(ii) You may talk with the collection site and laboratory to discuss time and temperature issues, including any pertinent information regarding specimen storage.
(iii) If you determine that time and temperature account for the pH value, you must cancel the test and take no further action, as provided at paragraph (a)(4) of this section.
(iv) If you determine that time and temperature fail to account for the pH value, you must cancel the test and direct another collection under direct observation, as provided at paragraph (a)(5) of this section.
(b) You may only report an invalid test result when you are in possession of a legible copy of Copy 1 of the CCF. In addition, you must have Copy 2 of the CCF, a legible copy of it, or any other copy of the CCF containing the employee's signature.
(c) If the employee admits to having adulterated or substituted the specimen, you must, on the same day, write and sign your own statement of what the employee told you. You must then report a refusal to test in accordance with § 40.163 .
(d) If the employee admits to using a drug, you must, on the same day, write and sign your own statement of what the employee told you. You must then report that admission to the DER for appropriate action under DOT Agency regulations. This test will be reported as cancelled with the reason noted.
(e) If the employee's recollection (required at paragraph (a)(5) of this section) results in another invalid result for the same reason as reported for the first specimen, as the MRO, you must:
(1) Review the CCF to ensure that there is documentation that the recollection was directly observed.
(2) If the CCF review indicates that the recollection was directly observed as required, document that the employee had another specimen with an invalid result for the same reason.
(3) Follow the recording and reporting procedures at (a)(4)(i) and (ii) of this section.
(4) If a negative result is required (i.e., pre-employment, return-to-duty, or follow-up tests), follow the procedures at § 40.160 for determining if there is clinical evidence that the individual is an illicit drug user.
(5) If the recollection was not directly observed as required, do not report a result but again explain to the DER that there must be an immediate recollection under direct observation.
(f) If the employee's recollection (required at paragraph (a)(5) of this section) results in another invalid result for a different reason than that reported for the first specimen, as the MRO, you must:
(1) Review the CCF to ensure that there is documentation that the recollection was directly observed.
(2) If the CCF review indicates that the recollection was directly observed as required, document that the employee had another specimen with an invalid result for a different reason.
(3) As the MRO, you should not contact the employee to discuss the result, but rather direct the DER to conduct an immediate recollection under direct observation without prior notification to the employee.
(4) If the CCF documentation indicates that the recollection was not directly observed as required, do not report a result but again explain to the DER that there must be an immediate recollection under direct observation.
(g) If, as the MRO, you receive a laboratory invalid result in conjunction with a positive, adulterated, and/or substituted result and you verify any of those results as being a positive and/or refusal to test, you do not report the invalid result unless the split specimen fails to reconfirm the result(s) of the primary specimen.
§ 40.160   What does the MRO do when a valid test result cannot be produced and a negative result is required?
(a) If a valid test result cannot be produced and a negative result is required, (under § 40.159 (a)(5)(iii) and (e)(4)), as the MRO, you must determine if there is clinical evidence that the individual is currently an illicit drug user. You must make this determination by personally conducting, or causing to be conducted, a medical evaluation. In addition, if appropriate, you may also consult with the employee's physician to gather information you need to reach this determination.
(b) If you do not personally conduct the medical evaluation, as the MRO, you must ensure that one is conducted by a licensed physician acceptable to you.
(c) For purposes of this section, the MRO or the physician conducting the evaluation may conduct an alternative test (e.g., blood) as part of the medically appropriate procedures in determining clinical evidence of drug use.
(d) If the medical evaluation reveals no clinical evidence of drug use, as the MRO, you must report this to the employer as a negative test result with written notations regarding the medical examination. The report must also state why the medical examination was required (i.e., either the basis for the determination that a permanent or long-term medical condition exists or because the recollection under direct observation resulted in another invalid result for the same reason, as appropriate) and for the determination that no signs and symptoms of drug use exist.
(1) Check “Negative” (Step 6) on the CCF.
(2) Sign and date the CCF.
(e) If the medical evaluation reveals clinical evidence of drug use, as the MRO, you must report the result to the employer as a cancelled test with written notations regarding the results of the medical examination. The report must also state why the medical examination was required (i.e., either the basis for the determination that a permanent or long-term medical condition exists or because the recollection under direct observation resulted in another invalid result for the same reason, as appropriate) and state the reason for the determination that signs and symptoms of drug use exist. Because this is a cancelled test, it does not serve the purpose of an actual negative test result (i.e., the employer is not authorized to allow the employee to begin or resume performing safety-sensitive functions, because a negative test result is needed for that purpose).
§ 40.161   What does the MRO do when a drug test specimen is rejected for testing?
As the MRO, when the laboratory reports that the specimen is rejected for testing ( e.g., because of a fatal or uncorrected flaw), you must do the following:
(a) Place a check mark in the “Test Cancelled” box (Step 6) on Copy 2 (or a legible copy of Copy 3-5) of the CCF and enter the reason on the “Remarks” line. If you do not have Copy 2 (or a legible copy of Copy 3-5), then enter “Test Cancelled” and the reason for the cancellation on a report in the format required under § 40.163(c).
(b) Report to the DER that the test is cancelled and the reason for cancellation, and that no further action is required unless a negative test is required ( e.g., in the case of a pre-employment, return-to-duty, or follow-up test).
(c) You may only report a test cancelled because of a “rejected for testing” laboratory result when you are in possession of a legible copy of Copy 1 of the CCF. In addition, you must have Copy 2 of the CCF, a legible copy of it, or any other copy of the CCF containing the employee's signature. If you do not have Copy 2 (or a legible copy of Copy 3-5), then enter “Test Cancelled” and the reason for the cancellation on a report in the format required under § 40.163(c).
§ 40.162   What must MROs do with multiple verified results for the same testing event?
(a) If the testing event is one in which there was one specimen collection with multiple verified non-negative results, as the MRO, you must report them all to the DER. For example, if you verified the specimen as being positive for marijuana and cocaine and as being a refusal to test because the specimen was also adulterated, as the MRO, you should report the positives and the refusal to the DER.
(b) If the testing event was one in which two separate specimen collections (e.g., a specimen out of temperature range and the subsequent observed collection) were sent to the laboratory, as the MRO, you must:
(1) If both specimens were verified negative, report the result as negative.
(2) If either of the specimens was verified negative and the other was verified as one or more non-negative(s), report the non-negative result(s) only. For example, if you verified one specimen as negative and the other as a refusal to test because the second specimen was substituted, as the MRO you should report only the refusal to the DER.
(i) If the first specimen is reported as negative, but the result of the second specimen has not been reported by the laboratory, as the MRO, you should hold—not report—the result of the first specimen until the result of the second specimen is received.
(ii) If the first specimen is reported as non-negative, as the MRO, you should report the result immediately and not wait to receive the result of the second specimen.
(3) If both specimens were verified non-negative, report all of the non-negative results. For example, if you verified one specimen as positive and the other as a refusal to test because the specimen was adulterated, as the MRO, you should report the positive and the refusal results to the DER.
(c) As an exception to paragraphs (a) and (b) of this section, as the MRO, you must follow procedures at § 40.159(g) when any verified non-negative result is also invalid.
§ 40.163   How does the MRO report drug test results?
(a) As the MRO, it is your responsibility to report all drug test results to the employer.
(b) You may use a signed or stamped and dated legible photocopy of Copy 2 of the CCF to report test results.
(c) If you do not report test results using Copy 2 of the CCF for this purpose, you must provide a written report (e.g., a letter) for each test result. This report must, as a minimum, include the following information:
(1) Full name, as indicated on the CCF, of the employee tested;
(2) Specimen ID number from the CCF and the SSN or employee ID No.;
(3) Reason for the test, if indicated on the CCF (e.g., random, post-accident);
(4) Date of the collection;
(5) Date you received Copy 2 of the CCF;
(6) Result of the test (i.e., positive, negative, dilute, refusal to test, test cancelled) and the date the result was verified by the MRO;
(7) For verified positive tests, the drug(s)/metabolite(s) for which the test was positive;
(8) For cancelled tests, the reason for cancellation; and
(9) For refusals to test, the reason for the refusal determination (e.g., in the case of an adulterated test result, the name of the adulterant).
(d) As an exception to the reporting requirements of paragraph (b) and (c) of this section, the MRO may report negative results using an electronic data file.
(1) If you report negatives using an electronic data file, the report must contain, as a minimum, the information specified in paragraph (c) of this section, as applicable for negative test results.
(2) In addition, the report must contain your name, address, and phone number, the name of any person other than you reporting the results, and the date the electronic results report is released.
(e) If you use a written report as provided in paragraph (c) of this section to report results, you must retain a copy of the written report. If you use the electronic data file to report negatives, as provided in paragraph (d) of this section, you must retain a retrievable copy of that report in a format suitable for inspection and audit by a DOT representative. In either case, you must keep the completed Copy 2 of the CCF. When completing Copy 2, either the MRO must sign and date it (for both negatives and non-negatives) or MRO staff must stamp and date it (for negatives only).
(f) You must not use Copy 1 of the CCF to report drug test results.
(g) You must not provide quantitative values to the DER or C/TPA for drug or validity test results. However, you must provide the test information in your possession to a SAP who consults with you (see § 40.293(g)).
(h) You must maintain reports and records related to negatives and cancelled results for one year; you must maintain reports and records related to positives and refusals for five years, unless otherwise specified by applicable DOT agency regulations.
§ 40.165   To whom does the MRO transmit reports of drug test results?
(a) As the MRO, you must report all drug test results to the DER, except in the circumstances provided for in § 40.345 .
(b) If the employer elects to receive reports of results through a C/TPA, acting as an intermediary as provided in § 40.345 , you must report the results through the designated C/TPA.
§ 40.167   How are MRO reports of drug results transmitted to the employer?
As the MRO or C/TPA who transmits drug test results to the employer, you must comply with the following requirements:
(a) You must report the results in a confidential manner.
(b) You must transmit to the DER on the same day the MRO verifies the result or the next business day all verified positive test results, results requiring an immediate collection under direct observation, adulterated or substituted specimen results, and other refusals to test.
(1) Direct telephone contact with the DER is the preferred method of immediate reporting. Follow up your phone call with appropriate documentation (see § 40.163).
(2) You are responsible for identifying yourself to the DER, and the DER must have a means to confirm your identification.
(3) The MRO's report that you transmit to the employer must contain all of the information required by § 40.163 .
(c) You must transmit the MRO's report(s) of verified tests to the DER so that the DER receives it within two days of verification by the MRO.
(1) You must fax, courier, mail, or electronically transmit a legible image or copy of either the signed or stamped and dated Copy 2 or the written report (see § 40.163(b) and (c)).
(2) Negative results reported electronically (i.e., computer data file) do not require an image of Copy 2 or the written report.
(d) In transmitting test results, you or the C/TPA and the employer must ensure the security of the transmission and limit access to any transmission, storage, or retrieval systems.
(e) MRO reports are not subject to modification or change by anyone other than the MRO, as provided in § 40.149(c).
§ 40.171   How does an employee request a test of a split specimen?
(a) As an employee, when the MRO has notified you that you have a verified positive drug test and/or refusal to test because of adulteration or substitution, you have 72 hours from the time of notification to request a test of the split specimen. The request may be verbal or in writing. If you make this request to the MRO within 72 hours, you trigger the requirements of this section for a test of the split specimen. There is no split specimen testing for an invalid result.
(b)(1) If, as an employee, you have not requested a test of the split specimen within 72 hours, you may present to the MRO information documenting that serious injury, illness, lack of actual notice of the verified test result, inability to contact the MRO (e.g., there was no one in the MRO's office and the answering machine was not working), or other circumstances unavoidably prevented you from making a timely request.
(2) As the MRO, if you conclude from the employee's information that there was a legitimate reason for the employee's failure to contact you within 72 hours, you must direct that the test of the split specimen take place, just as you would when there is a timely request.
(c) When the employee makes a timely request for a test of the split specimen under paragraphs (a) and (b) of this section, you must, as the MRO, immediately provide written notice to the laboratory that tested the primary specimen, directing the laboratory to forward the split specimen to a second HHS-certified laboratory. You must also document the date and time of the employee's request.
§ 40.173   Who is responsible for paying for the test of a split specimen?
(a) As the employer, you are responsible for making sure (e.g., by establishing appropriate accounts with laboratories for testing split specimens) that the MRO, first laboratory, and second laboratory perform the functions noted in §§ 40.175-40.185 in a timely manner, once the employee has made a timely request for a test of the split specimen.
(b) As the employer, you must not condition your compliance with these requirements on the employee's direct payment to the MRO or laboratory or the employee's agreement to reimburse you for the costs of testing. For example, if you ask the employee to pay for some or all of the cost of testing the split specimen, and the employee is unwilling or unable to do so, you must ensure that the test takes place in a timely manner, even though this means that you pay for it.
(c) As the employer, you may seek payment or reimbursement of all or part of the cost of the split specimen from the employee (e.g., through your written company policy or a collective bargaining agreement). This part takes no position on who ultimately pays the cost of the test, so long as the employer ensures that the testing is conducted as required and the results released appropriately.
§ 40.175   What steps does the first laboratory take with a split specimen?
(a) As the laboratory at which the primary and split specimen first arrive, you must check to see whether the split specimen is available for testing.
(b) If the split specimen is unavailable or appears insufficient, you must then do the following:
(1) Continue the testing process for the primary specimen as you would normally. Report the results for the primary specimen without providing the MRO information regarding the unavailable split specimen.
(2) Upon receiving a letter from the MRO instructing you to forward the split specimen to another laboratory for testing, report to the MRO that the split specimen is unavailable for testing. Provide as much information as you can about the cause of the unavailability.
(c) As the laboratory that tested the primary specimen, you are not authorized to open the split specimen under any circumstances (except when the split specimen is redesignated as provided in § 40.83).
(d) When you receive written notice from the MRO instructing you to send the split specimen to another HHS-certified laboratory, you must forward the following items to the second laboratory:
(1) The split specimen in its original specimen bottle, with the seal intact;
(2) A copy of the MRO's written request; and
(3) A copy of Copy 1 of the CCF, which identifies the drug(s)/metabolite(s) or the validity criteria to be tested for.
(e) You must not send to the second laboratory any information about the identity of the employee. Inadvertent disclosure does not, however, cause a fatal flaw.
(f) This subpart does not prescribe who gets to decide which HHS-certified laboratory is used to test the split specimen. That decision is left to the parties involved.
§ 40.177   What does the second laboratory do with the split specimen when it is tested to reconfirm the presence of a drug or drug metabolite?
(a) As the laboratory testing the split specimen, you must test the split specimen for the drug(s)/drug metabolite(s) confirmed in the primary specimen.
(b) You must conduct this test without regard to the cutoff concentrations of § 40.85 or § 40.91, as applicable.
(c) If the test fails to reconfirm the presence of the drug(s)/drug metabolite(s) that were reported in the primary specimen, you must conduct validity tests in an attempt to determine the reason for being unable to reconfirm the presence of the drug(s)/metabolite(s). You should conduct the same validity tests as you would conduct on a primary specimen set forth in § 40.87 or § 40.93, as applicable.
(d) In addition, if the test fails to reconfirm the presence of the drug(s)/ drug metabolite(s) reported in the primary specimen, you may send the specimen or an aliquot of it for testing at another HHS-certified laboratory that has the capability to conduct another reconfirmation test.